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510(k) K902220

PRECIPATH(R) IM NORMAL & ABNORMAL IMMUNO. CONTROL by Boehringer Mannheim Corp. — Product Code DGR

K902220 is an FDA 510(k) premarket notification submitted by Boehringer Mannheim Corp. for the device "PRECIPATH(R) IM NORMAL & ABNORMAL IMMUNO. CONTROL". The FDA issued a decision of Substantially Equivalent on September 5, 1990. The device falls under product code DGR (Whole Human Serum, Antigen, Antiserum, Control), a Class I device regulated under 21 CFR 866.5700. Boehringer Mannheim Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 5, 1990
Date Received
May 17, 1990
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Whole Human Serum, Antigen, Antiserum, Control
Device Class
Class I
Regulation Number
866.5700
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 DGR

  • K961544 — QUALITROL IGAME CONTROLS, LEVELS 1 AND 2 (September 24, 1996)
  • K865014 — LIQUICHEK IMMUNOLOGY CONTROL (HUMAN) LEVELS I & II (January 9, 1987)
  • K790298 — RADIOASSAY, CONTROL SERUM I, II, III (April 4, 1979)
  • K781355 — ICS NORMAL CONTROL SERUM (August 31, 1978)

FDA data resources