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510(k) K864082

REFLOTRON(R) ALT (GPT) by Boehringer Mannheim Corp. — Product Code CKD

K864082 is an FDA 510(k) premarket notification submitted by Boehringer Mannheim Corp. for the device "REFLOTRON(R) ALT (GPT)". The FDA issued a decision of Substantially Equivalent on December 4, 1986. The device falls under product code CKD (Hydrazone Colorimetry, Alt/Sgpt), a Class I device regulated under 21 CFR 862.1030. Boehringer Mannheim Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 4, 1986
Date Received
October 20, 1986
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Hydrazone Colorimetry, Alt/Sgpt
Device Class
Class I
Regulation Number
862.1030
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 CKD

  • K991834 — CHOLESTECH LDX ALANINE AMINOTRANSFERASE (ALT), MODEL 11-772 (September 9, 1999)
  • K941192 — ORTHO ALT MICROWELL TEST SYSTEM (May 16, 1995)
  • K896237 — COBAS READY ALT REAGENT (February 16, 1990)
  • K884784 — VIRGO(R) MICROWELL ALT ASSAY (December 29, 1988)
  • K883387 — ALANINE AMINO TRANSFERASE (COLORIMETRIC METHOD) (October 13, 1988)
  • K860485 — SGPT (ALT) REAGENT SET (COLORIMETRIC) (April 3, 1986)
  • K844283 — SGPT REAGENT SET (November 27, 1984)
  • K841059 — SGPT REAGENT SET (May 1, 1984)
  • K821207 — SGPT REAGENT SET (July 14, 1982)
  • K820491 — SGPT REAGENT SET (March 11, 1982)

FDA data resources