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510(k) K821660

BIO-CHECK GRAM STAIN CONTROL by American Scientific Products — Product Code JTR

K821660 is an FDA 510(k) premarket notification submitted by American Scientific Products for the device "BIO-CHECK GRAM STAIN CONTROL". The FDA issued a decision of Substantially Equivalent on June 25, 1982. The device falls under product code JTR (Kit, Quality Control For Culture Media), a Class I device regulated under 21 CFR 866.2480. American Scientific Products has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 25, 1982
Date Received
June 4, 1982
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 American Scientific Products

  • K864824 — INFECTIOUS TISSUE KIT (December 24, 1986)
  • K844042 — BLOOD DILUTION VIAL (October 23, 1984)
  • K831634 — GLUCOSE REAGENT B6360-11 (July 19, 1983)
  • K831626 — UREA NITROGEN-BUN-REAGENTS B6370-11A (July 7, 1983)
  • K831625 — UREA NITROGEN-BUN-REAGENTS B6360-12 (July 7, 1983)
  • K831628 — CREATININE REAGENTS B6370-13 (July 6, 1983)
  • K831627 — CREATININE REAGENTS B6360-10 (July 6, 1983)
  • K831624 — GLUCOSE REAGENT KITS-B6370-10A (July 6, 1983)
  • K831569 — REAGENT CUPS (June 30, 1983)
  • K831571 — ROTOR (June 30, 1983)

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)
  • K830133 — Q-CHECK CULTI-LOOPS (February 9, 1983)
  • K822954 — MICROTECH BACTERIAL CONTROLS (November 16, 1982)
  • K820064 — SUSCEPTROL (January 28, 1982)

FDA data resources