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FDA 510(k)

REAGENT FOR DETERM. GLUTAMIC-PYRUVIC-

K-Number: K800689 · 1980-05-30

ApplicantDiagnostic Solutions, Inc.
Decision Date1980-05-30
Product CodeCKA
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

REAGENT FOR DETERM. GLUTAMIC-PYRUVIC- is the device name listed in this FDA 510(k) record. The listed applicant is Diagnostic Solutions, Inc.. It received FDA 510(k) clearance on 1980-05-30 under 510(k) number K800689. 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 REAGENT FOR DETERM. GLUTAMIC-PYRUVIC-?

REAGENT FOR DETERM. GLUTAMIC-PYRUVIC- is a medical device that received FDA 510(k) clearance on 1980-05-30. The listed applicant is Diagnostic Solutions, Inc.. The 510(k) number is K800689.

When did REAGENT FOR DETERM. GLUTAMIC-PYRUVIC- receive FDA 510(k) clearance?

REAGENT FOR DETERM. GLUTAMIC-PYRUVIC- received FDA 510(k) clearance on 1980-05-30, under 510(k) number K800689.

Who is the listed applicant for REAGENT FOR DETERM. GLUTAMIC-PYRUVIC-?

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

What is the FDA product code for REAGENT FOR DETERM. GLUTAMIC-PYRUVIC-?

The FDA product code for REAGENT FOR DETERM. GLUTAMIC-PYRUVIC- is CKA.

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Other records listing Diagnostic Solutions, 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.

K934892RELIEF PLUS ONE REAGENT STRIP MODIFICATIONK924398UNI-CHECK REAGENT STRIPK921825QUICK-CHECK II REAGENT STRIPK800681REAGENTS FOR DETERM. CO2 IN HUMAN SERUMK800677REAGENTS FOR DETERM. SERUM IRON IN HUMANK800682REAGENTS FOR DETERM. CHOLESTEROL/SERUM

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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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