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FDA 510(k)

NDC#12739-0010-1 C-ZYME GPT

K-Number: K760194 · 1976-08-03

ApplicantCoulter Electronics, Inc.
Decision Date1976-08-03
Product CodeCKA
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

NDC#12739-0010-1 C-ZYME GPT is the device name listed in this FDA 510(k) record. The listed applicant is Coulter Electronics, Inc.. It received FDA 510(k) clearance on 1976-08-03 under 510(k) number K760194. 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 NDC#12739-0010-1 C-ZYME GPT?

NDC#12739-0010-1 C-ZYME GPT is a medical device that received FDA 510(k) clearance on 1976-08-03. The listed applicant is Coulter Electronics, Inc.. The 510(k) number is K760194.

When did NDC#12739-0010-1 C-ZYME GPT receive FDA 510(k) clearance?

NDC#12739-0010-1 C-ZYME GPT received FDA 510(k) clearance on 1976-08-03, under 510(k) number K760194.

Who is the listed applicant for NDC#12739-0010-1 C-ZYME GPT?

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

What is the FDA product code for NDC#12739-0010-1 C-ZYME GPT?

The FDA product code for NDC#12739-0010-1 C-ZYME GPT is CKA.

Other records listing Coulter Electronics, Inc. as applicant

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Related Devices (Code: CKA)

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.

K120945HITACHI CLINICAL ANALYZER S TEST REAGENT CARTRIDGE ALT, HITACHI CLINICAL ANALYZER S TEST REAGENT CARTRIDGE ASTHitachi Chemical Diagnostics, Inc.K113382ACE ALT REAGENTAlfa WassermannK061020DIMENSION VISTA ALBUMIN, ALKALINE PHOSPHATASE, ASPARTATE AMINO TRANSFERASE, CARBAMAZEPINE & ALANINE AMINO TRANSFERASEDade Behring, Inc.K020487CARESIDE ALTCareside, Inc.K980028ALT (GPT) LIQUID STABLE 2 VIAL - INCORPORATING DYNAMIC STABILIZATION TECHNOLOGY - (DST)Trace America, Inc.K973869TRACE REAGENT LINE FOR THE COBAS MIRATrace America, Inc.

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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