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510(k) K895880

PANCREATIC A-AMYLASE EPS by Boehringer Mannheim Corp. — Product Code CIL

K895880 is an FDA 510(k) premarket notification submitted by Boehringer Mannheim Corp. for the device "PANCREATIC A-AMYLASE EPS". The FDA issued a decision of Substantially Equivalent on December 19, 1989. The device falls under product code CIL (Cresol Red Colorimetry, Carbon-Dioxide), a Class II device regulated under 21 CFR 862.1160. Boehringer Mannheim Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 19, 1989
Date Received
October 5, 1989
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Cresol Red Colorimetry, Carbon-Dioxide
Device Class
Class II
Regulation Number
862.1160
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 CIL

  • K922953 — SYSTEMATE CALCIUM TEST TECHNICON RA 1000 (September 9, 1992)
  • K833724 — ENZYMATIC CO2 (December 29, 1983)
  • K800111 — CO2 CONTENT (February 13, 1980)

FDA data resources