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510(k) K822445

HCT CENTRIFUGE by Boehringer Mannheim Corp. — Product Code GKG

K822445 is an FDA 510(k) premarket notification submitted by Boehringer Mannheim Corp. for the device "HCT CENTRIFUGE". The FDA issued a decision of Substantially Equivalent on September 14, 1982. The device falls under product code GKG (Centrifuge, Hematocrit), a Class II device regulated under 21 CFR 864.6400. Boehringer Mannheim Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 14, 1982
Date Received
August 16, 1982
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Centrifuge, Hematocrit
Device Class
Class II
Regulation Number
864.6400
Review Panel
HE
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 GKG

  • K961803 — SPUNCRIT (MODEL DRC-40) (July 5, 1996)
  • K955795 — MULTI-CENTRIFUGE (March 29, 1996)
  • K930415 — MICROHEMATOCRIT ROTOR (March 23, 1993)
  • K925863 — SPUNCRIT (February 5, 1993)
  • K920207 — HERMLE Z230H (June 9, 1992)
  • K920759 — CRITSPIN MICRO-HEMATOCRIT (April 29, 1992)
  • K913128 — HEMATASTAT C-70B (September 23, 1991)
  • K890849 — HEMATASTAT H-70 (March 21, 1989)
  • K821803 — QBC CENTRIFUGAL HEMATOLOGY SYSTEM (September 14, 1982)
  • K813033 — CLAY ADAMS QBC CENTRIFUGAL HEMOTOLOGY (April 9, 1982)

FDA data resources