FDA 510(k)

SINGLE VIAL 10 SGOT-TRIS

K-Number: K780634 · 1978-05-18

Decision Date1978-05-18

Product CodeCIT

Advisory CommitteeCH

DecisionSubstantially Equivalent

Device Summary

SINGLE VIAL 10 SGOT-TRIS 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 1978-05-18 under 510(k) number K780634. The device is classified under product code CIT. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SINGLE VIAL 10 SGOT-TRIS?

SINGLE VIAL 10 SGOT-TRIS is a medical device that received FDA 510(k) clearance on 1978-05-18. The listed applicant is Boehringer Mannheim Corp.. The 510(k) number is K780634.

When did SINGLE VIAL 10 SGOT-TRIS receive FDA 510(k) clearance?

SINGLE VIAL 10 SGOT-TRIS received FDA 510(k) clearance on 1978-05-18, under 510(k) number K780634.

Who is the listed applicant for SINGLE VIAL 10 SGOT-TRIS?

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 SINGLE VIAL 10 SGOT-TRIS?

The FDA product code for SINGLE VIAL 10 SGOT-TRIS is CIT.

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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.