FDA guidance

Guidance for 510(k)s on Cholesterol Tests for Clinical Laboratory, Physicians' Office…

FDA guidance · issued Jul 12, 1995

Key facts

Title Guidance for 510(k)s on Cholesterol Tests for Clinical Laboratory, Physicians' Office Laboratory and Home Use
Issue date Jul 12, 1995

At a glance

  • 10–99 Product codes referenced
  • 1–9 Recognized standards referenced

Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.

About FDA guidance documents

FDA guidance documents describe the agency's current thinking on regulatory topics. Drafts are issued for comment before a final version is published.

Source: U.S. Food and Drug Administration (FDA), Guidance Documents

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