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510(k) K061549

AMNIOSTAT-FLM-PG by Irvine Scientific Sales Co., Inc. — Product Code JHG

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 18, 2006
Date Received
June 5, 2006
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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Other clearances for product code JHG

  • K871593 — TDXR FETAL LUNG MATURITY (July 20, 1987)
  • K834616 — AMNIO STAT-FLM AGGLUTINATION TEST (May 25, 1984)
  • K822150 — AMNISTAT-FLM (October 21, 1982)
  • K813216 — SECURE FDI TEST KIT (December 17, 1981)
  • K811588 — HELENA FETAL-TEK 200 METHOD (June 25, 1981)
  • K790798 — FETAL MATURITY TEST PROCEDURE (June 5, 1979)