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510(k) K902220

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

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

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  • 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 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)