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510(k) K871943

D.A.T. (TM) AMYLASE REAGENT by Behring Diagnostics, Inc. — Product Code CIJ

K871943 is an FDA 510(k) premarket notification submitted by Behring Diagnostics, Inc. for the device "D.A.T. (TM) AMYLASE REAGENT". The FDA issued a decision of Substantially Equivalent on June 3, 1987. The device falls under product code CIJ (Saccharogenic, Amylase), a Class II device regulated under 21 CFR 862.1070. Behring Diagnostics, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 3, 1987
Date Received
May 19, 1987
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Saccharogenic, Amylase
Device Class
Class II
Regulation Number
862.1070
Review Panel
CH
Submission Type

Other clearances by Behring Diagnostics, Inc.

  • K973832 — OPUS HLH CONTROLS (October 27, 1997)
  • K972929 — N ANTISERUM TO HUMAN ALBUMIN (October 20, 1997)
  • K972840 — N ANTISERUM TO HUMAN TRANSFERRIN (October 17, 1997)
  • K973202 — MODIFICATION OF OPUS FERRITIN TEST SYSTEM (September 12, 1997)
  • K972316 — OPUS D-DIMER (September 9, 1997)
  • K972116 — VON WILLEBRAND REAGENT (July 25, 1997)
  • K972011 — OPUS ETHANOL (July 22, 1997)
  • K971596 — EMIT II OPIATES 300/2000 ASSAY (June 25, 1997)
  • K971600 — EMIT CALIBRATOR B LEVEL 1 (CUTOFF)/EMIT CALIBRATOR B LEVEL 2 (HIGH) (June 25, 1997)
  • K964595 — OPUS PSA TEST SYSTEM (June 24, 1997)

Other clearances for product code CIJ

  • K023396 — AMYLASE EPS-G7 (LIQUID) REAGENT SET, (HITACHI ANALYZERS) (December 23, 2002)
  • K991817 — ADDITIONAL IMS ASSAYS FOR THE BAYER ADVIA IMS SYSTEM (July 22, 1999)
  • K980013 — AMYLASE (February 4, 1998)
  • K953211 — AMYLASE (ETHYLIDENE PNGPG7) KIT (June 21, 1996)
  • K951494 — AMYLASE TEST ITEM 97381/94 (R1, 97382/94 (R2-SR) (December 11, 1995)
  • K940735 — LIQUID AMYLASE (CNPG3) REAGENT SET (August 1, 1994)
  • K940010 — DMA AMYLASE (DEMAND) PROCEDURE (March 11, 1994)
  • K931301 — OLYMPUS AMYLASE REAGENT (October 18, 1993)
  • K931141 — BIOTROL AMYLASE CNPG3 (May 26, 1993)
  • K882225 — -AMYLASE EPS (January 3, 1989)

FDA data resources