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FDA 510(k)

LIQUID ALT(SGPT) REAGENT SET

K-Number: K941287 · 1994-05-03

ApplicantPointe Scientific, Inc.,
Decision Date1994-05-03
Product CodeCKA
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

LIQUID ALT(SGPT) REAGENT SET is the device name listed in this FDA 510(k) record. The listed applicant is Pointe Scientific, Inc.,. It received FDA 510(k) clearance on 1994-05-03 under 510(k) number K941287. 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 LIQUID ALT(SGPT) REAGENT SET?

LIQUID ALT(SGPT) REAGENT SET is a medical device that received FDA 510(k) clearance on 1994-05-03. The listed applicant is Pointe Scientific, Inc.,. The 510(k) number is K941287.

When did LIQUID ALT(SGPT) REAGENT SET receive FDA 510(k) clearance?

LIQUID ALT(SGPT) REAGENT SET received FDA 510(k) clearance on 1994-05-03, under 510(k) number K941287.

Who is the listed applicant for LIQUID ALT(SGPT) REAGENT SET?

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

What is the FDA product code for LIQUID ALT(SGPT) REAGENT SET?

The FDA product code for LIQUID ALT(SGPT) REAGENT SET is CKA.

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Other records listing Pointe Scientific, 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.

K070757MICROPROTEIN REAGENT SETK062118POINTE 360K070251CARBON DIOXIDE LIQUID STABLE REAGENTK070207MULTI-ANALYTE CHEMISTRY CALIBRATORK070504AMMONIA/ALCOHOL CONTROL SETK061377APOLIPOPROTEIN A1 AND APOLIPOPROTEIN B REAGENTS AND CALIBRATORS

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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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