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510(k) K842579

B.E.C. GROWTH CHEK MICROBIAL SUSPENSIONS by Biological & Environmental Control Laboratories — Product Code JTR

K842579 is an FDA 510(k) premarket notification submitted by Biological & Environmental Control Laboratories for the device "B.E.C. GROWTH CHEK MICROBIAL SUSPENSIONS". The FDA issued a decision of Substantially Equivalent on July 27, 1984. The device falls under product code JTR (Kit, Quality Control For Culture Media), a Class I device regulated under 21 CFR 866.2480. Biological & Environmental Control Laboratories has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 27, 1984
Date Received
July 3, 1984
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 Biological & Environmental Control Laboratories

  • K971500 — ACCESS SYSTEMS NEEDLELESS VIAL ADAPTER (August 18, 1997)
  • K962802 — SAFE MATE I.V. FLUID DELIVERY SETS (August 28, 1996)
  • K962801 — SAFE MATE I.V. EXTENSION SETS (August 28, 1996)
  • K961328 — BEC SHROUDED PLASTIC CANNULA (May 30, 1996)
  • K961327 — BEC NEEDLELESS INJECTION SITE (May 15, 1996)
  • K863635 — UPDATED STERILE ENDOTRACHEAL BRUSHES (November 3, 1986)
  • K863633 — SAFETY PINS, ELASTIC BANDAGES & STOCKINETTES (October 16, 1986)
  • K863636 — UPDATED STERILE GENERAL HOSPITAL INSTRUMENTS (October 6, 1986)
  • K863637 — UPDATED STERILE GOWNS, MASKS AND TOWELS (September 29, 1986)
  • K863632 — UPDATED STERILE PROCEDURAL KIT (September 29, 1986)

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)
  • 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