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510(k) K811588

HELENA FETAL-TEK 200 METHOD by Helena Laboratories — Product Code JHG

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 25, 1981
Date Received
June 8, 1981
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Chromatographic Separation, Lecithin/Sphingomyelin Ratio
Device Class
Class II
Regulation Number
862.1455
Review Panel
CH
Submission Type

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  • K790798 — FETAL MATURITY TEST PROCEDURE (June 5, 1979)