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510(k) K880844

ALBUMIN REAGENT SET by Tech-Neal Scientific, Inc. — Product Code CIX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 5, 1988
Date Received
February 26, 1988
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Bromcresol Green Dye-Binding, Albumin
Device Class
Class II
Regulation Number
862.1035
Review Panel
CH
Submission Type

Other clearances by Tech-Neal Scientific, Inc.

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  • K881241 — TOTAL BILIRUBIN REAGENT (May 27, 1988)
  • K881240 — CHLORIDE REAGENT SET (April 28, 1988)
  • K880237 — CHOLESTEROL (April 28, 1988)
  • K881237 — CREATINE KINASE (CK) REAGENT SET (April 28, 1988)
  • K880277 — URIC ACID REAGENT SET (April 18, 1988)
  • K880843 — CREATININE REAGENT SET (KINETIC) (April 5, 1988)
  • K880845 — CALCIUM REAGENT SET (April 5, 1988)

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