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510(k) K821934

BIO-CAL OPERATION CHECK KIT by Bio-Analytics Laboratories, Inc. — Product Code JIS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 20, 1982
Date Received
June 29, 1982
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Calibrator, Primary
Device Class
Class II
Regulation Number
862.1150
Review Panel
CH
Submission Type

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  • K851514 — ULTRA-VIOLET GLUCOSE REAGENT (May 20, 1985)
  • K850639 — ENZYMATIC ALPHA-AMYLASE REAGENT KIT (March 5, 1985)
  • K832771 — ERYTHROCYTE TEST (October 28, 1983)
  • K832567 — ACETAMINOPHEN(PARACETAMOL (September 12, 1983)
  • K831414 — COLORIMETRIC BUN (June 16, 1983)
  • K813431 — SALICYLATES (March 25, 1982)

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