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510(k) K862392

BIOTIS MOTILITY TEST MEDIUM by Otisville Biotech, Inc. — Product Code JSF

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, Single Biochemical Test
Device Class
Class I
Regulation Number
866.2320
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)
  • K862394 — BIOTIS MITIS SALIVARIUS (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 JSF

  • K880946 — NUTRIENT GELATIN - PRODUCT NUMBER T2860 (April 1, 1988)
  • K880120 — MOELLERS DECARBOXYLASE, LYSINE (March 31, 1988)
  • K880119 — MOELLERS DECARBOXYLASE, ONITHINE (March 31, 1988)
  • K880126 — LAURYL TRYPTOSE BROTH (March 31, 1988)
  • K880112 — CYSTINE TRYPTIC MEDIUM W/ MALTOSE (March 30, 1988)
  • K880113 — CYSTINE TRYPTIC MEDIUM W/LACTOSE (March 30, 1988)
  • K880106 — ACETAMIDE AGAR SLANT (March 30, 1988)
  • K880111 — CYSTINE TRYPTIC MEDIUM W/SUCROSE (March 30, 1988)
  • K880135 — NITRATE BROTH (March 30, 1988)
  • K880139 — ONPG TEST REAGENT (March 30, 1988)