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510(k) K830133

Q-CHECK CULTI-LOOPS by Lab Ability, Inc. — Product Code JTR

K830133 is an FDA 510(k) premarket notification submitted by Lab Ability, Inc. for the device "Q-CHECK CULTI-LOOPS". The FDA issued a decision of Substantially Equivalent on February 9, 1983. The device falls under product code JTR (Kit, Quality Control For Culture Media), a Class I device regulated under 21 CFR 866.2480. Lab Ability, Inc. has at least 4 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 9, 1983
Date Received
January 13, 1983
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 Lab Ability, Inc.

  • K833407 — SELECTO-DISC NOVOBIOCIN 5UG (December 30, 1983)
  • K832436 — SELECTRO-DISC (September 26, 1983)
  • K830134 — Q-CHECK REAGENT STANDARDS (January 9, 1983)
  • K813191 — SHIGELLA SERA-CHEK (December 3, 1981)

Other clearances for product code JTR

  • K871121 — PROTECT T.M. (April 14, 1987)
  • 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)
  • K822954 — MICROTECH BACTERIAL CONTROLS (November 16, 1982)
  • K821660 — BIO-CHECK GRAM STAIN CONTROL (June 25, 1982)
  • K820064 — SUSCEPTROL (January 28, 1982)

FDA data resources