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510(k) K821184

SPIN CHEM REAGENTS & STANDARDS by Smithkline Diagnostics, Inc. — Product Code JIY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 24, 1982
Date Received
April 27, 1982
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Photometric Method, Iron (Non-Heme)
Device Class
Class I
Regulation Number
862.1410
Review Panel
CH
Submission Type

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  • K821674 — SPINCHEM ACID PHOSPHATASE REAGENT (June 22, 1982)

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