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510(k) K834474

H.P.T. HOME PREG. TEST KIT & A.P.T. by Biomedical Research & Development Laboratories, Inc. — Product Code LCX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 28, 1984
Date Received
December 20, 1983
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Kit, Test, Pregnancy, Hcg, Over The Counter
Device Class
Class II
Regulation Number
862.1155
Review Panel
CH
Submission Type

Other clearances by Biomedical Research & Development Laboratories, Inc.

  • K884693 — UNIVERSAL(TM) ION SELECT ELECTRODE STANDARDS (December 15, 1988)
  • K881655 — SPECTRUM(TM) BLOOD GAS AND ELECTROLYTE CONTROL (May 27, 1988)

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