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510(k) K832771

ERYTHROCYTE TEST by Bio-Analytics Laboratories, Inc. — Product Code LKZ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 28, 1983
Date Received
August 16, 1983
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Red-Cell Count By Photometry
Device Class
Class II
Regulation Number
864.7100
Review Panel
HE
Submission Type

Other clearances by Bio-Analytics Laboratories, Inc.

  • K861638 — KINETIC ALKALINE PHOSPHATASE REAGENT KIT (May 29, 1986)
  • K860245 — ENZYMATIC ALPHA-AMYLASE REAGENT KIT (March 14, 1986)
  • K860213 — ALBUMIN REAGENT KIT (February 11, 1986)
  • K851513 — ULTRA-VIOLET BUN REAGENT KIT (May 20, 1985)
  • K851514 — ULTRA-VIOLET GLUCOSE REAGENT (May 20, 1985)
  • K850639 — ENZYMATIC ALPHA-AMYLASE REAGENT KIT (March 5, 1985)
  • K832567 — ACETAMINOPHEN(PARACETAMOL (September 12, 1983)
  • K831414 — COLORIMETRIC BUN (June 16, 1983)
  • K821934 — BIO-CAL OPERATION CHECK KIT (July 20, 1982)
  • K813431 — SALICYLATES (March 25, 1982)

Other clearances for product code LKZ

  • K833708 — COMPUR* M1000 HEMOGLOBIN & ERYTHROCYTE (January 4, 1984)