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510(k) K780439

PRECIMAT GLYCEROL by Boehringer Mannheim Corp. — Product Code JGW

K780439 is an FDA 510(k) premarket notification submitted by Boehringer Mannheim Corp. for the device "PRECIMAT GLYCEROL". The FDA issued a decision of Substantially Equivalent on April 18, 1978. The device falls under product code JGW (Fluorometric Method, Triglycerides), a Class I device regulated under 21 CFR 862.1705. Boehringer Mannheim Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 18, 1978
Date Received
March 20, 1978
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Fluorometric Method, Triglycerides
Device Class
Class I
Regulation Number
862.1705
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)
  • K982948 — ELECSYS PSA, MODEL # ELECSYS 1010 (October 27, 1998)

Other clearances for product code JGW

  • K872912 — TRIGLYCERIDE (UV) REAGENT (August 17, 1987)
  • K852556 — TDX REA TRIGLYCERIDES (July 22, 1985)

FDA data resources