FDA 510(k)

TWIN GOT-AST IFCC/GPT-ALT IFCC

K-Number: K861792 · 1986-07-29

Decision Date1986-07-29

Product CodeCKA

Advisory CommitteeCH

DecisionSubstantially Equivalent

Device Summary

TWIN GOT-AST IFCC/GPT-ALT IFCC is the device name listed in this FDA 510(k) record. The listed applicant is Boehringer Mannheim Corp.. It received FDA 510(k) clearance on 1986-07-29 under 510(k) number K861792. The device is classified under product code CKA. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TWIN GOT-AST IFCC/GPT-ALT IFCC?

TWIN GOT-AST IFCC/GPT-ALT IFCC is a medical device that received FDA 510(k) clearance on 1986-07-29. The listed applicant is Boehringer Mannheim Corp.. The 510(k) number is K861792.

When did TWIN GOT-AST IFCC/GPT-ALT IFCC receive FDA 510(k) clearance?

TWIN GOT-AST IFCC/GPT-ALT IFCC received FDA 510(k) clearance on 1986-07-29, under 510(k) number K861792.

Who is the listed applicant for TWIN GOT-AST IFCC/GPT-ALT IFCC?

The FDA 510(k) record lists Boehringer Mannheim Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for TWIN GOT-AST IFCC/GPT-ALT IFCC?

The FDA product code for TWIN GOT-AST IFCC/GPT-ALT IFCC is CKA.

Other records listing Boehringer Mannheim Corp. as applicant

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Official Source

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