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510(k) K811570

ANTIBODY TO CHLAMYDIA TRACHOMATIS by Electro-Nucleonics Laboratories, Inc. — Product Code GPW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 23, 1981
Date Received
June 4, 1981
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Antigen, Cf, Psittacosis (Chlamydia Group)
Device Class
Class I
Regulation Number
866.3120
Review Panel
MI
Submission Type

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Other clearances for product code GPW

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  • K844868 — CHLAMYDIA GROUP CF ANTIGEN (March 5, 1985)