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510(k) K914419

AMNIOTEST(TM) by Pro-Lab, Inc. — Product Code HIO

K914419 is an FDA 510(k) premarket notification submitted by Pro-Lab, Inc. for the device "AMNIOTEST(TM)". The FDA issued a decision of Substantially Equivalent on September 1, 1993. The device falls under product code HIO (Sampler, Amniotic Fluid (Amniocentesis Tray)), a Class I device regulated under 21 CFR 884.1550. Pro-Lab, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 1, 1993
Date Received
October 3, 1991
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Sampler, Amniotic Fluid (Amniocentesis Tray)
Device Class
Class I
Regulation Number
884.1550
Review Panel
OB
Submission Type

Other clearances by Pro-Lab, Inc.

  • K934383 — PROLEX (STREPTOCCAL GROUPING LATEX KIT) (January 27, 1995)
  • K921421 — LEGIONELLA REAGENS FOR DIRECT FLUORESCENT ANTIBODY (July 28, 1992)
  • K903714 — E. COLI 0157 LATEX TEST (January 24, 1991)
  • K894221 — ROSCO PYRR (September 28, 1989)
  • K883996 — X-ACT LDC/IND (October 12, 1988)
  • K883995 — X-ACT UREA/TDA (October 12, 1988)
  • K871121 — PROTECT T.M. (April 14, 1987)
  • K870117 — NEISSERIA/BRANHAMELLA DIFFERENTIAL TEST (March 20, 1987)
  • K861142 — MASTER KIT B (July 10, 1986)
  • K861889 — D'ALA RAPID TEST (June 3, 1986)

Other clearances for product code HIO

  • K960203 — G.E. STERILE AMNIOCENTESIS TRAY (March 14, 1996)
  • K955679 — RNS STERILE, DISPOSABLE AMNIOCENTESIS TRAY (March 12, 1996)
  • K922960 — VARIOUS CAMEO MED AMNIOCENTESIS TRAYS, DISPOSABLE (November 5, 1992)
  • K921738 — SONO-VU US(TM), MODIFICATION (April 27, 1992)
  • K915863 — MEGA AMNIOCENTESIS KIT (March 30, 1992)
  • K904583 — SONO-VU US(TM) (June 24, 1991)
  • K901643 — ISOFLO(TM) AMNIOCENTESIS TRAY (July 25, 1990)
  • K900021 — PERCU-SET(TM) (March 29, 1990)
  • K896031 — AMNIOTIC FLUID SAMPLER (AMNIOCENTESIS TRAY) (January 12, 1990)
  • K894031 — PHARMASEAL GENETIC AMNIOCENTESIS TRAY (August 4, 1989)

FDA data resources