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510(k) K050328

PREGNANCY-SKREEN by Biochemical Diagnostic, Inc. — Product Code JJX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 29, 2005
Date Received
February 9, 2005
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Single (Specified) Analyte Controls (Assayed And Unassayed)
Device Class
Class I
Regulation Number
862.1660
Review Panel
CH
Submission Type

Other clearances by Biochemical Diagnostic, Inc.

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  • K904181 — ANTI-GBM ANTIBODIES QUANTITATIVE KIT (September 10, 1991)
  • K841831 — CANNU-SKREEN-PRELIMINARY (July 6, 1984)

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