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510(k) K782156

UNITEST CREATINE KINASE by Boehringer Mannheim Corp. — Product Code JLB

K782156 is an FDA 510(k) premarket notification submitted by Boehringer Mannheim Corp. for the device "UNITEST CREATINE KINASE". The FDA issued a decision of Substantially Equivalent on March 2, 1979. The device falls under product code JLB (Atp And Creatine Kinase (Enzymatic), Creatine), a Class I device regulated under 21 CFR 862.1210. Boehringer Mannheim Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 2, 1979
Date Received
December 22, 1978
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Atp And Creatine Kinase (Enzymatic), Creatine
Device Class
Class I
Regulation Number
862.1210
Review Panel
CH
Submission Type

Other clearances by Boehringer Mannheim Corp.

  • K984326 — ELECYS IGE ASSAY (February 8, 1999)
  • K983047 — ACCU-CHEK HQ SYSTEM (February 5, 1999)
  • K984419 — ELECSYS IGE CALCHECK (February 2, 1999)
  • K984425 — MODIFICATION OF PRECISET SERUM PROTEINS CALIBRATOR (January 20, 1999)
  • K984372 — ELECSYS CALCHECK TROPONIN T (December 14, 1998)
  • K984105 — ELECSYS TROPONIN T STAT TEST (December 8, 1998)
  • K983503 — ROCHE DIAGNOSTICS, BOEHRINGER MANNHEIM CORPORATION INORGANIC PHOSPHORUS REAGENT (December 1, 1998)
  • K983469 — PRECISET SERUM PROTEINS CALIBRATOR (November 25, 1998)
  • K983185 — BOEHRINGER MANNHEIM TINA-QUANT IGE TEST (November 12, 1998)
  • K982949 — ELECSYS PSA, MODEL 2010 (October 27, 1998)

Other clearances for product code JLB

  • K992140 — PICCOLO METLYTE 7 REAGENT DISC (August 26, 1999)
  • K971817 — OLYMPUS CK-MB REAGENT (June 11, 1997)

FDA data resources