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FDA 510(k)

CENTRIFICHEM ALT/AGPT OPTIMIZED REAGENT

K-Number: K811694 · 1981-07-01

ApplicantBaker Instructions Corp.
Decision Date1981-07-01
Product CodeCKA
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

CENTRIFICHEM ALT/AGPT OPTIMIZED REAGENT is the device name listed in this FDA 510(k) record. The listed applicant is Baker Instructions Corp.. It received FDA 510(k) clearance on 1981-07-01 under 510(k) number K811694. 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 CENTRIFICHEM ALT/AGPT OPTIMIZED REAGENT?

CENTRIFICHEM ALT/AGPT OPTIMIZED REAGENT is a medical device that received FDA 510(k) clearance on 1981-07-01. The listed applicant is Baker Instructions Corp.. The 510(k) number is K811694.

When did CENTRIFICHEM ALT/AGPT OPTIMIZED REAGENT receive FDA 510(k) clearance?

CENTRIFICHEM ALT/AGPT OPTIMIZED REAGENT received FDA 510(k) clearance on 1981-07-01, under 510(k) number K811694.

Who is the listed applicant for CENTRIFICHEM ALT/AGPT OPTIMIZED REAGENT?

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

What is the FDA product code for CENTRIFICHEM ALT/AGPT OPTIMIZED REAGENT?

The FDA product code for CENTRIFICHEM ALT/AGPT OPTIMIZED REAGENT is CKA.

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Other records listing Baker Instructions 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.

K882612SYSTEM 9000 DIFF MODEL AUTOMATED CELL COUNTERK873596BAKER TDM THEOPHYLLINE ASSAYK870603SYSTEM 9000 AUTOMATED CELL COUNTERK854173UCD URINE SPECIMEN COLLECTORK850386SYSTEM 8000 CELL COUNTERK833116SPIRIT CHEMISTRY SYSTEM

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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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