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FDA 510(k)

CREATINE KINASE ISOENZYME SUBSTRATE SET

K-Number: K771605 · 1977-09-15

ApplicantPfizer Pharmaceuticals
Decision Date1977-09-15
Product CodeJHX
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

CREATINE KINASE ISOENZYME SUBSTRATE SET is the device name listed in this FDA 510(k) record. The listed applicant is Pfizer Pharmaceuticals. It received FDA 510(k) clearance on 1977-09-15 under 510(k) number K771605. The device is classified under product code JHX. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CREATINE KINASE ISOENZYME SUBSTRATE SET?

CREATINE KINASE ISOENZYME SUBSTRATE SET is a medical device that received FDA 510(k) clearance on 1977-09-15. The listed applicant is Pfizer Pharmaceuticals. The 510(k) number is K771605.

When did CREATINE KINASE ISOENZYME SUBSTRATE SET receive FDA 510(k) clearance?

CREATINE KINASE ISOENZYME SUBSTRATE SET received FDA 510(k) clearance on 1977-09-15, under 510(k) number K771605.

Who is the listed applicant for CREATINE KINASE ISOENZYME SUBSTRATE SET?

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

What is the FDA product code for CREATINE KINASE ISOENZYME SUBSTRATE SET?

The FDA product code for CREATINE KINASE ISOENZYME SUBSTRATE SET is JHX.

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Other records listing Pfizer Pharmaceuticals 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.

K885321WATER JEL STERILE GEL-SOAKED BURN DRESSINGK810427CEFOTAXIME 30MCG ANTIMICROBIAL SUSCEP.K802408E-VAC BLOOD CULTURE SYSTEMK770801MICROBIO. PROD. FLUORESCENT ANTIBODYK770425NEEDLES, STERILE, AIRWAY

Related Devices (Code: JHX)

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.

K234005Access CK-MBBeckman Coulter, Inc.K212648VITROS Immunodiagnostic Products CK-MB Reagent PackOrtho Clinical DiagnosticsK163462AQT90 FLEX Myo Test Kit, AQT90 FLEX CKMB Test Kit, AQT90 FLEXRadiometer Medical ApsK120326AQT90 FLEX CKMB TEST KIT, AQT90 FLEX LQC MULTI-CHECK, LEVELS 1-3, AQT90 FLEX CKMB CAL CARTRIDGERadiometer Medical ApsK081360PATHFAST CK-MB-II, PATHFAST MYO-IIMitsubishi Kagaku IatronK051650STRATUS CS ACUTE CARE MB ISOENZYME OF CREATINE KINASE (CKMB) TEST PAK; STRATUS CS ACUTE CARE CKMB TESTPAK.Dade Behring, Inc.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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