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510(k) K810534

GEMENI QUICK-MB SEPARATION KIT by Gemini, Inc. — Product Code JHT

K810534 is an FDA 510(k) premarket notification submitted by Gemini, Inc. for the device "GEMENI QUICK-MB SEPARATION KIT". The FDA issued a decision of Substantially Equivalent on March 11, 1981. The device falls under product code JHT (Chromatographic Separation, Cpk Isoenzymes), a Class II device regulated under 21 CFR 862.1215. Gemini, Inc. has at least 1 other 510(k) clearance on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 11, 1981
Date Received
February 26, 1981
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 Gemini, Inc.

  • K810870 — GEMENI CK-MB ISOENZYME ABNORMAL SERUM (April 14, 1981)

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)
  • 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