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FDA 510(k)

ALT OR SGPT

K-Number: K971323 · 1997-04-21

ApplicantCarolina Liquid Chemistries Corp.
Decision Date1997-04-21
Product CodeCKA
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

ALT OR SGPT is the device name listed in this FDA 510(k) record. The listed applicant is Carolina Liquid Chemistries Corp.. It received FDA 510(k) clearance on 1997-04-21 under 510(k) number K971323. 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 ALT OR SGPT?

ALT OR SGPT is a medical device that received FDA 510(k) clearance on 1997-04-21. The listed applicant is Carolina Liquid Chemistries Corp.. The 510(k) number is K971323.

When did ALT OR SGPT receive FDA 510(k) clearance?

ALT OR SGPT received FDA 510(k) clearance on 1997-04-21, under 510(k) number K971323.

Who is the listed applicant for ALT OR SGPT?

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

What is the FDA product code for ALT OR SGPT?

The FDA product code for ALT OR SGPT is CKA.

Other records listing Carolina Liquid Chemistries Corp. 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.

K213211Carolina Liquid Chemistries Cocaine and Cocaine Metabolite Enzyme Immunoassay (COCM) Test SystemK972073TOTAL BILIRUBIN REAGENTK971907CALCIUM REAGENTK971324TRIGLYCERIDES, TG, OR TRIGK971967BUNK971908CREA OR CREATININE

View all 18 devices →

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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