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510(k) K871121

PROTECT T.M. by Pro-Lab, Inc. — Product Code JTR

K871121 is an FDA 510(k) premarket notification submitted by Pro-Lab, Inc. for the device "PROTECT T.M.". The FDA issued a decision of Substantially Equivalent on April 14, 1987. The device falls under product code JTR (Kit, Quality Control For Culture Media), a Class I device regulated under 21 CFR 866.2480. Pro-Lab, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 14, 1987
Date Received
March 19, 1987
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Kit, Quality Control For Culture Media
Device Class
Class I
Regulation Number
866.2480
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)
  • K903714 — E. COLI 0157 LATEX TEST (January 24, 1991)
  • K894221 — ROSCO PYRR (September 28, 1989)
  • K883995 — X-ACT UREA/TDA (October 12, 1988)
  • K883996 — X-ACT LDC/IND (October 12, 1988)
  • K870117 — NEISSERIA/BRANHAMELLA DIFFERENTIAL TEST (March 20, 1987)
  • K861142 — MASTER KIT B (July 10, 1986)
  • K861888 — HIPPURATE HYDROLYSIS TEST (June 3, 1986)

Other clearances for product code JTR

  • K862914 — FEKAL CHECK PARASITOLOGY CONTROL SLIDE (September 16, 1986)
  • K861022 — KWIK STIK(TM) LYFO(TM) DISK MICROORGANISMS (April 4, 1986)
  • K855198 — INDI KWIK (TM) CO/TWO KIT (January 14, 1986)
  • K842579 — B.E.C. GROWTH CHEK MICROBIAL SUSPENSIONS (July 27, 1984)
  • K842129 — LYFO-DISK MICROORGANISMS (July 3, 1984)
  • K831653 — LYOPHILIZED MICROORGANISMS (July 28, 1983)
  • K830133 — Q-CHECK CULTI-LOOPS (February 9, 1983)
  • K822954 — MICROTECH BACTERIAL CONTROLS (November 16, 1982)
  • K821660 — BIO-CHECK GRAM STAIN CONTROL (June 25, 1982)
  • K820064 — SUSCEPTROL (January 28, 1982)

FDA data resources