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FDA 510(k)

AMHS BLOOD ANALY. TRIGLYCEOIDES REAG. KI

K-Number: K771004 · 1977-09-12

ApplicantMiles Laboratories, Inc.
Decision Date1977-09-12
Product CodeCDT
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

AMHS BLOOD ANALY. TRIGLYCEOIDES REAG. KI is the device name listed in this FDA 510(k) record. The listed applicant is Miles Laboratories, Inc.. It received FDA 510(k) clearance on 1977-09-12 under 510(k) number K771004. The device is classified under product code CDT. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AMHS BLOOD ANALY. TRIGLYCEOIDES REAG. KI?

AMHS BLOOD ANALY. TRIGLYCEOIDES REAG. KI is a medical device that received FDA 510(k) clearance on 1977-09-12. The listed applicant is Miles Laboratories, Inc.. The 510(k) number is K771004.

When did AMHS BLOOD ANALY. TRIGLYCEOIDES REAG. KI receive FDA 510(k) clearance?

AMHS BLOOD ANALY. TRIGLYCEOIDES REAG. KI received FDA 510(k) clearance on 1977-09-12, under 510(k) number K771004.

Who is the listed applicant for AMHS BLOOD ANALY. TRIGLYCEOIDES REAG. KI?

The FDA 510(k) record lists Miles Laboratories, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for AMHS BLOOD ANALY. TRIGLYCEOIDES REAG. KI?

The FDA product code for AMHS BLOOD ANALY. TRIGLYCEOIDES REAG. KI is CDT.

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Related Devices (Code: CDT)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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