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510(k) K771605

CREATINE KINASE ISOENZYME SUBSTRATE SET by Pfizer Pharmaceuticals — Product Code JHX

K771605 is an FDA 510(k) premarket notification submitted by Pfizer Pharmaceuticals for the device "CREATINE KINASE ISOENZYME SUBSTRATE SET". The FDA issued a decision of Substantially Equivalent on September 15, 1977. The device falls under product code JHX (Fluorometric Method, Cpk Or Isoenzymes), a Class II device regulated under 21 CFR 862.1215. Pfizer Pharmaceuticals has at least 5 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 15, 1977
Date Received
August 22, 1977
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Fluorometric Method, Cpk Or Isoenzymes
Device Class
Class II
Regulation Number
862.1215
Review Panel
CH
Submission Type

Other clearances by Pfizer Pharmaceuticals

  • K885321 — WATER JEL STERILE GEL-SOAKED BURN DRESSING (March 22, 1989)
  • K810427 — CEFOTAXIME 30MCG ANTIMICROBIAL SUSCEP. (March 31, 1981)
  • K802408 — E-VAC BLOOD CULTURE SYSTEM (October 23, 1980)
  • K770801 — MICROBIO. PROD. FLUORESCENT ANTIBODY (May 25, 1977)
  • K770425 — NEEDLES, STERILE, AIRWAY (April 15, 1977)

Other clearances for product code JHX

  • K234005 — Access CK-MB (February 16, 2024)
  • K212648 — VITROS Immunodiagnostic Products CK-MB Reagent Pack (January 28, 2022)
  • K163462 — AQT90 FLEX Myo Test Kit, AQT90 FLEX CKMB Test Kit, AQT90 FLEX (September 21, 2017)
  • K120326 — AQT90 FLEX CKMB TEST KIT, AQT90 FLEX LQC MULTI-CHECK, LEVELS 1-3, AQT90 FLEX CKM (November 21, 2012)
  • K081360 — PATHFAST CK-MB-II, PATHFAST MYO-II (August 17, 2009)
  • K051650 — STRATUS CS ACUTE CARE MB ISOENZYME OF CREATINE KINASE (CKMB) TEST PAK; STRATUS C (September 8, 2005)
  • K041596 — ARCHITECT STAT CK-MB IMMUNOASSAY (July 21, 2004)
  • K033747 — RAMP CK-MB ASSAY (May 17, 2004)
  • K034055 — IMMULITE 2500 CK-MB, 2500 MYOGLOBIN, 2500 STAT TROPONIN I (January 21, 2004)
  • K030012 — CK-MB AND CK-MB CALIBRATORS ON THE ACCESS IMMUNOASSAY SYSTEMS, MODELS 386371 AND (January 17, 2003)

FDA data resources