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FDA 510(k)

NDC#12739-0011-1 C-ZYME GOT

K-Number: K760193 · 1976-08-03

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

Device Summary

NDC#12739-0011-1 C-ZYME GOT 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 K760193. 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 NDC#12739-0011-1 C-ZYME GOT?

NDC#12739-0011-1 C-ZYME GOT 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 K760193.

When did NDC#12739-0011-1 C-ZYME GOT receive FDA 510(k) clearance?

NDC#12739-0011-1 C-ZYME GOT received FDA 510(k) clearance on 1976-08-03, under 510(k) number K760193.

Who is the listed applicant for NDC#12739-0011-1 C-ZYME GOT?

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#12739-0011-1 C-ZYME GOT?

The FDA product code for NDC#12739-0011-1 C-ZYME GOT is CIT.

Other records listing Coulter Electronics, Inc. as applicant

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.

K923951CD8 CYTOSPHERES KITK930119COULTER RETIC-C CELL CONTROLK921279CD4 CYTOSPHERES KITK923530COULTER MULTI-Q-PREPK922181COULTER MH009K922704COULTER MAXM W/ AUTOLOADER

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Related Devices (Code: CIT)

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.

K093883AST/GOT 4+1 SL, AST/GOT 4+1 SL, ELICAL 2, ELITROL I, ELITROL II, MODEL ASSL-0250, ASSL-0455, CALI-0580, CONT-0080, CONT-Seppim S.A.S.K080485ASPARTATE AMINO TRANSFERASE (AST/SGOT) TEST SYSTEM, ASAT (GOT) FSDiasys Diagnostics Systems GmbHK071525ACTIVATED ASPARTATE AMINOTRANSFERASEAbbott LaboratoriesK071580AST/GOT (IFCC), PYRIDOXAL PHOSPHATE, ECAL, NORTROL AND ABTROLThermofisher Scientific OYK071211COBAS C 111 ANALYZERRoche DiagnosticsK060318HEPATIC ENZYMES ON ABX PENTRA 400 CLINICAL CHEMISTRY ANALYZERHoriba Abx

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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