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510(k) K862394

BIOTIS MITIS SALIVARIUS by Otisville Biotech, Inc. — Product Code JSI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 3, 1986
Date Received
June 24, 1986
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

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

Other clearances by Otisville Biotech, Inc.

  • K862397 — BIOTIS DECARBOXYLASE MEDIA, LYSINE (July 3, 1986)
  • K862398 — BIOTIS DECARBOXYLASE MEDIA, ORNITHINE (July 3, 1986)
  • K862390 — BIOTIS BORDET GENGOU AGAR (July 3, 1986)
  • K862395 — BIOTIS DECARBOXYLASE MEDIA, BASE (July 3, 1986)
  • K862388 — BIOTIS TCBS AGAR (July 3, 1986)
  • K862392 — BIOTIS MOTILITY TEST MEDIUM (July 3, 1986)
  • K862389 — BIOTIS ACETAMIDE AGAR (July 3, 1986)
  • K862387 — BIOTIS HAEMOPHILUS IDENTIFICATION QUAD (July 3, 1986)
  • K862399 — BIOTIS SXT AGAR (July 3, 1986)
  • K862396 — BIOTIS DECARBOXYLASE MEDIA, ARGININE (July 3, 1986)

Other clearances for product code JSI

  • K070691 — BBL CHROMAGAR 0157 (November 20, 2007)
  • K974428 — DIPSTREAK (July 30, 1998)
  • K891593 — LISTERIA SELECTIVE ENRICHMENT MEDIUM (June 9, 1989)
  • K890199 — DENTOCULT SM-STRIP MUTANS (March 2, 1989)
  • K882182 — SALMONELLA-SHIGELLA (SS) AGAR - PRODUCT #P3326 (June 6, 1988)
  • K881572 — XL AGAR BASE (April 18, 1988)
  • K881577 — MODIFIED SELECTIVE STREPTOCOCCUS AGAR (April 18, 1988)
  • K881576 — SELENITE BROTH (April 18, 1988)
  • K881555 — TINSDALE AGAR BASE (April 18, 1988)
  • K881556 — TRICHOMONAS BROTH (April 18, 1988)