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510(k) K880610

UNIMETER CALIBRATION KIT by Boehringer Mannheim Corp. — Product Code JIW

K880610 is an FDA 510(k) premarket notification submitted by Boehringer Mannheim Corp. for the device "UNIMETER CALIBRATION KIT". The FDA issued a decision of Substantially Equivalent on March 24, 1988. The device falls under product code JIW (Calibrator, Surrogate), a Class II device regulated under 21 CFR 862.1150. Boehringer Mannheim Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 24, 1988
Date Received
February 12, 1988
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Calibrator, Surrogate
Device Class
Class II
Regulation Number
862.1150
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 JIW

  • K973055 — WAKO CH50 LINEARITY SET (September 25, 1997)
  • K970396 — HUMAN CHORIONIC GONADOTROPIN CALIBRATOR (February 20, 1997)
  • K910255 — FLOW CYTOMETRY FITC/PE COMPENSATION KIT (April 3, 1991)
  • K902575 — SOPHEIA 1000 (S1CAL) & SOPHEIA 2000 (S2CAL) (October 4, 1990)
  • K902294 — ACCUSCAN MICROBEAD STANDARDS (July 3, 1990)
  • K892213 — ACS COLLOID OSMOTIC PRESSURE CALIBRATOR (June 21, 1989)
  • K883389 — RAICHEM(TM) BILIRUBIN CONJUGATE STANDARD (December 14, 1988)
  • K882220 — CALIBRATION KIT (August 2, 1988)
  • K880654 — AMRESCO LIQUIZYME GLUCOSE/BUN STANDARD 0124, 0200 (June 7, 1988)
  • K854028 — AUDIT AUTOMATED BLOOD CHEMISTRY ANALYZER (December 2, 1985)

FDA data resources