Home / 510(k) Clearances / K790798

510(k) K790798

FETAL MATURITY TEST PROCEDURE by Helena Laboratories — Product Code JHG

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 5, 1979
Date Received
April 17, 1979
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 Helena Laboratories

  • K213396 — SPIFE A1AT kit (October 13, 2022)
  • K192931 — V8 Nexus Hemoglobin Ultrascreen, V8 AFSA2 Hemo Control (April 19, 2022)
  • K131479 — V8 SP NORMAL CONTROL, ABNORMAL CONTROL (October 7, 2013)
  • K100103 — SPECIALTY ASSAYED CONTROL-2 (December 15, 2010)
  • K061991 — PLATELETWORKS ARACHIDONIC ACID, MODEL PW-ACA (February 23, 2007)
  • K061069 — SPIFE IFE-15 PENTAVALENT, MODEL 3456, SPIFE IFE-9 PENTAVALENT KIT, MODEL 3457, S (July 6, 2006)
  • K061014 — ACTALYKE QC KIT, MODELS AQC-HP AND AQC-LP (May 10, 2006)
  • K050053 — HEMORAM/AGGRAM ANALYZER (July 11, 2005)
  • K024162 — SPIFE 3000 TITAN GEL IGG IEF KIT, MODEL 3389 (February 19, 2003)
  • K023761 — PLATELETWORKS, MODELS PW-A, PW-C (February 14, 2003)

Other clearances for product code JHG

  • K061549 — AMNIOSTAT-FLM-PG (October 18, 2006)
  • 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)