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510(k) K841836

SELECTIVE CULTURE MED. TRICHOMONAS by Microline Scientific — Product Code JSD

K841836 is an FDA 510(k) premarket notification submitted by Microline Scientific for the device "SELECTIVE CULTURE MED. TRICHOMONAS". The FDA issued a decision of Substantially Equivalent on May 14, 1984. The device falls under product code JSD (Culture Media, Selective Broth), a Class I device regulated under 21 CFR 866.2360. Microline Scientific has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 14, 1984
Date Received
April 17, 1984
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Culture Media, Selective Broth
Device Class
Class I
Regulation Number
866.2360
Review Panel
MI
Submission Type

Other clearances by Microline Scientific

  • K841586 — CHOCOLATE AGAR (May 31, 1984)
  • K841842 — DIFFERENTIAL CULTURE MED. MACCONKEY AGAR (May 31, 1984)
  • K841843 — DIFFERENTIAL CULTURE MED. LEVINE EMB (May 31, 1984)
  • K841844 — DIFFERENTIAL CULTURE MEDIUM-BIGGY AGAR (May 31, 1984)
  • K841845 — SELECTIVE CULTURE MED. COLUMBIA CNA (May 31, 1984)
  • K841841 — DIFFERENTIAL CULTURE MED. MANNITOL SALT (May 25, 1984)
  • K841839 — SELECTIVE CULTURE MED. SELECTIVE STREP (May 25, 1984)
  • K841840 — SELECTIVE CULTURE MED. PHENYLETHYL ALCO (May 25, 1984)
  • K841837 — ENRICHED CULTURE MED. FLUID THIOGLYC0 (May 21, 1984)
  • K841838 — ENRICHED CULTURE MED. TRYPTIC SOY AGAR (May 21, 1984)

Other clearances for product code JSD

  • K883075 — FASTIDIOUS INOCULUM BROTH (August 15, 1988)
  • K880107 — CAMPY BROTH (March 30, 1988)
  • K873324 — SABOURAUD DEXTROSE (SD) BROTH TUBE, #T3331 (October 2, 1987)
  • K873218 — BRAIN HEART INFUSION BROTH W/6.5% NAC1 - #T3802 (September 23, 1987)
  • K871447 — TODD HEWITT W/CNA (LIM BROTH) (May 13, 1987)
  • K871640 — ALKALINE PEPTONE WATER (May 13, 1987)
  • K870594 — T9802 TSB W/6.5% NACL (March 30, 1987)
  • K853609 — APL TRYPTIC SOY BROTH (September 12, 1985)
  • K844547 — TRYPTIC SOY BROTH W/6.5%SODIUM CHLORIDE (January 16, 1985)
  • K840971 — SELECTIVE CULTURE MEDIUM (April 13, 1984)

FDA data resources