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FDA 510(k)

CYMET-AUTOMATED

K-Number: K771788 · 1977-10-07

ApplicantJ.T. Baker Chemical Co.
Decision Date1977-10-07
Product CodeGGK
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

CYMET-AUTOMATED is the device name listed in this FDA 510(k) record. The listed applicant is J.T. Baker Chemical Co.. It received FDA 510(k) clearance on 1977-10-07 under 510(k) number K771788. The device is classified under product code GGK. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CYMET-AUTOMATED?

CYMET-AUTOMATED is a medical device that received FDA 510(k) clearance on 1977-10-07. The listed applicant is J.T. Baker Chemical Co.. The 510(k) number is K771788.

When did CYMET-AUTOMATED receive FDA 510(k) clearance?

CYMET-AUTOMATED received FDA 510(k) clearance on 1977-10-07, under 510(k) number K771788.

Who is the listed applicant for CYMET-AUTOMATED?

The FDA 510(k) record lists J.T. Baker Chemical Co. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CYMET-AUTOMATED?

The FDA product code for CYMET-AUTOMATED is GGK.

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Other records listing J.T. Baker Chemical Co. 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.

K803128SERIES 810 PLATELET ANALYZERK802080BAKER DIAG. ULTRARATE CHLORIDE KITK801909LSA 290 ASSAY REAGENTS/NEPHELOMETRICK802035BAKER DIAG. ULTRARATE CO2 REAGENT KITK801795BAKER DIAGNOSTIC ULTRA-RATE SODIUM/POT.K801661J.T. BAKER CERULOPLASMIN NEPHELOMETRIC

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Related Devices (Code: GGK)

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.

K883836COULTER CLONE QUICK STAIN WHOLE BLOOD LYSE-IICoulter ImmunologyK883991KVM HEMOGLOBIN LYSING REAGENTKvm Technologies, Inc.K874054FISHER DIAGNOSTICS HEMATALL III LAS REAGENTFisher Scientific Co., LLCK873348CELL-DYN DIFF SCREEN, AUTO. & SEMI AUTO. LYTIC AG.Abbott DiagnosticsK863114PIASTRINITJ. D. Assoc.K863503HEMOLYSEReagent Laboratory, 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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