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510(k) K834616

AMNIO STAT-FLM AGGLUTINATION TEST by Hana Biologics, Inc. — Product Code JHG

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 25, 1984
Date Received
December 14, 1983
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

Other clearances by Hana Biologics, Inc.

  • K883682 — CHANG MEDIUM (ADDITIONAL INDICATIONS) (September 16, 1988)
  • K855205 — MYCOTRIM TM VL TRIPHASIC CULTURE SYSTEM (February 5, 1986)
  • K833933 — ACE COLOR TEST (March 23, 1984)
  • K822736 — MYCOTRIUM-GU (December 3, 1982)
  • K822737 — MYCOTRIUM-RS (December 3, 1982)
  • K822150 — AMNISTAT-FLM (October 21, 1982)
  • K812820 — CHANG MEDIUM (November 10, 1981)

Other clearances for product code JHG

  • K061549 — AMNIOSTAT-FLM-PG (October 18, 2006)
  • K871593 — TDXR FETAL LUNG MATURITY (July 20, 1987)
  • 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)