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510(k) K850246

MASTER KIT A by Pro-Lab, Inc.

K850246 is an FDA 510(k) premarket notification submitted by Pro-Lab, Inc. for the device "MASTER KIT A". The FDA issued a decision of Substantially Equivalent on April 9, 1985. Pro-Lab, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 9, 1985
Date Received
January 22, 1985
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

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)
  • 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)

FDA data resources