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510(k) K790772

CHEMTAB by Boehringer Mannheim Corp. — Product Code JIM

K790772 is an FDA 510(k) premarket notification submitted by Boehringer Mannheim Corp. for the device "CHEMTAB". The FDA issued a decision of Substantially Equivalent on June 15, 1979. The device falls under product code JIM (Method, Metallic Reduction, Glucose (Urinary, Non-Quantitative)), a Class II device regulated under 21 CFR 862.1340. Boehringer Mannheim Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 15, 1979
Date Received
April 20, 1979
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Method, Metallic Reduction, Glucose (Urinary, Non-Quantitative)
Device Class
Class II
Regulation Number
862.1340
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 JIM

  • K902155 — HI CHEM ISE REAGENTS (PRODUCTS #88960 AND #88964) (June 12, 1990)

FDA data resources