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510(k) K903714

E. COLI 0157 LATEX TEST by Pro-Lab, Inc. — Product Code GNA

K903714 is an FDA 510(k) premarket notification submitted by Pro-Lab, Inc. for the device "E. COLI 0157 LATEX TEST". The FDA issued a decision of Substantially Equivalent on January 24, 1991. The device falls under product code GNA (Antisera, All Types, Escherichia Coli), a Class I device regulated under 21 CFR 866.3255. Pro-Lab, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 24, 1991
Date Received
August 14, 1990
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Antisera, All Types, Escherichia Coli
Device Class
Class I
Regulation Number
866.3255
Review Panel
MI
Submission Type

Other clearances by Pro-Lab, Inc.

  • K934383 — PROLEX (STREPTOCCAL GROUPING LATEX KIT) (January 27, 1995)
  • K914419 — AMNIOTEST(TM) (September 1, 1993)
  • K921421 — LEGIONELLA REAGENS FOR DIRECT FLUORESCENT ANTIBODY (July 28, 1992)
  • 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 GNA

  • K071799 — MODIFICATION TO BIOSTAR OIA SHIGATOX (October 2, 2007)
  • K031367 — DUOPATH VEROTOXINS GLISA TEST (January 23, 2004)
  • K993401 — DRYSPOT E.COLI 0157 KIT (February 28, 2000)
  • K981734 — VTEC-RPLA SEIKEN (September 22, 1998)
  • K962028 — WELLCOLEX E-COLI OI57 ZC60 (November 1, 1996)
  • K953362 — PREMIER EHEC (November 14, 1995)
  • K950167 — PREMIER EHEC (April 14, 1995)
  • K933457 — RIM E.COLI 0157:H7 LATEX TEST (April 20, 1994)
  • K884026 — ESCHERICHIA COLI 0157 LATEX AGGLUTINATION TEST KIT (February 3, 1989)
  • K874288 — PHADEBACT ETEC-LT TEST (September 2, 1988)

FDA data resources