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510(k) K781009

ANALYZER, SERUM IRON & TOTAL IRON BINDIN by Environmental Sciences Assoc., Inc. — Product Code JMD

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 27, 1978
Date Received
June 19, 1978
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Radioimmunoassay, Total Estrogens, Nonpregnancy
Device Class
Class I
Regulation Number
862.1275
Review Panel
CH
Submission Type

Other clearances by Environmental Sciences Assoc., Inc.

  • K801439 — MODEL 5100 ELECTROCHEMICAL DETECTOR (July 21, 1980)

Other clearances for product code JMD

  • K791651 — TOTAL ESTROGENS KIT BY RIA (September 27, 1979)