Home / 510(k) Clearances / K823550

510(k) K823550

CK-ISOZYME U.V. REAGENT SET by Gelman Sciences, Inc. — Product Code JHT

K823550 is an FDA 510(k) premarket notification submitted by Gelman Sciences, Inc. for the device "CK-ISOZYME U.V. REAGENT SET". The FDA issued a decision of Substantially Equivalent on January 7, 1983. The device falls under product code JHT (Chromatographic Separation, Cpk Isoenzymes), a Class II device regulated under 21 CFR 862.1215. Gelman Sciences, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 7, 1983
Date Received
November 30, 1982
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 Gelman Sciences, Inc.

  • K946190 — DRUG DISPENSING SPIKE (March 17, 1995)
  • K943127 — PHARMASSURE LARGE VOLUME TRANSFER FILTERS (September 29, 1994)
  • K941589 — SYRINGE FILTER DEVICES (September 6, 1994)
  • K941020 — DRUG RECONSTITUTION FILTER DEVICE (August 10, 1994)
  • K942275 — VIAL VENT FILTER (July 26, 1994)
  • K941032 — UNKNOWN (May 27, 1994)
  • K910821 — TRANSDUCER PROTECTOR (August 12, 1991)
  • K892387 — MODIFIED GELMAN ARTERIAL FILTER (June 22, 1989)
  • K884176 — CHROMATOGRAPHY KIT (April 4, 1989)
  • K884178 — DRUG CONTROL SET (February 17, 1989)

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)
  • K904866 — COULTER CK-MB ISOENZYME REAGENT (December 13, 1990)
  • K904721 — DSL CK-MB (DSL #3200) (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)
  • K874284 — SHOT-GUN ISOLAT PROCED/MEASUREMENT CK-MB IN SERUM (January 21, 1988)
  • K872041 — COULTER DART CK-MB ISOENZYME REAGENT SYSTEM (September 16, 1987)

FDA data resources