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510(k) K874284

SHOT-GUN ISOLAT PROCED/MEASUREMENT CK-MB IN SERUM by Diagnostic Chemicals, Ltd. (Usa) — Product Code JHT

K874284 is an FDA 510(k) premarket notification submitted by Diagnostic Chemicals, Ltd. (Usa) for the device "SHOT-GUN ISOLAT PROCED/MEASUREMENT CK-MB IN SERUM". The FDA issued a decision of Substantially Equivalent on January 21, 1988. The device falls under product code JHT (Chromatographic Separation, Cpk Isoenzymes), a Class II device regulated under 21 CFR 862.1215. Diagnostic Chemicals, Ltd. (Usa) has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 21, 1988
Date Received
October 14, 1987
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Chromatographic Separation, Cpk Isoenzymes
Device Class
Class II
Regulation Number
862.1215
Review Panel
CH
Submission Type

Other clearances by Diagnostic Chemicals, Ltd. (Usa)

  • K022538 — IMMUNODIP URINARY ALBUMIN SCREEN ASSAY, CATALOGUE NUMBER 790-25 (August 23, 2002)
  • K974874 — BILIRUBIN-SL (TOTAL) ASSAY (February 12, 1998)
  • K932556 — AMMONIA ASSAY CAT. NO. 200-02 (August 2, 1994)
  • K932766 — HDL-CHOLESTRAL(DEXTRAN SULFATE/MAGNESIUM) (December 10, 1993)
  • K932555 — DC-LINEATE CAT. NO. SE-091 (August 19, 1993)
  • K925877 — DC-UIBC-CAL (March 18, 1993)
  • K912825 — MAGNESIUM ASSAY KIT, CAT.# 100-12 (July 26, 1991)
  • K895964 — DCL SYPHILIS-M CATALOG NO. 600-80 (January 8, 1991)
  • K895965 — DCL - SYPHILIS-G ASSAY CATALOG NO. 600-70 (December 26, 1990)
  • K904660 — ENZYMATIC BILIRUBIN (TOTAL), CATALOGUE NO. 202-14 (November 20, 1990)

Other clearances for product code JHT

  • K022409 — SPECTRAL'S CARDIAC STATUS CK-MB RAPID TEST (September 30, 2002)
  • K991299 — MODIFICATION TO CARDIAC STATUS CK-MB/MYOGLOBIN RAPID ONE-STEP TEST, LIFESIGN MI (May 28, 1999)
  • K930359 — CARDIO REP-CAT. NO. 1400 & CK ISOFORMS KIT 3305 (April 12, 1993)
  • K904721 — DSL CK-MB (DSL #3200) (December 13, 1990)
  • K904866 — COULTER CK-MB ISOENZYME REAGENT (December 13, 1990)
  • K901450 — MODIFIED LABEL FOR EMBRIA-CK, QUICK-MB/MICROMI-MB (May 15, 1990)
  • K896170 — REP CK ISOFORMS KIT CAT. NO. 3081, 3082, 3083 (February 16, 1990)
  • K881168 — CREATINE KINASE (CK) ISOENZYME MB (November 10, 1988)
  • K872041 — COULTER DART CK-MB ISOENZYME REAGENT SYSTEM (September 16, 1987)
  • K872598 — MICROMI-CK(TM) (August 3, 1987)

FDA data resources