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510(k) K860409

BIOTIS COLUMBIA SHEEP BLOOD AGAR by Otisville Biotech, Inc. — Product Code JSG

Clearance Details

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

Device Classification

Device Name
Culture Media, Non-Selective And Non-Differential
Device Class
Class I
Regulation Number
866.2300
Review Panel
MI
Submission Type

Other clearances by Otisville Biotech, Inc.

  • K862390 — BIOTIS BORDET GENGOU AGAR (July 3, 1986)
  • K862396 — BIOTIS DECARBOXYLASE MEDIA, ARGININE (July 3, 1986)
  • K862387 — BIOTIS HAEMOPHILUS IDENTIFICATION QUAD (July 3, 1986)
  • K862398 — BIOTIS DECARBOXYLASE MEDIA, ORNITHINE (July 3, 1986)
  • K862397 — BIOTIS DECARBOXYLASE MEDIA, LYSINE (July 3, 1986)
  • K862400 — BIOTIS KV LAKED BLOOD AGAR (July 3, 1986)
  • K862393 — BIOTIS LITMUS MILK (July 3, 1986)
  • K862395 — BIOTIS DECARBOXYLASE MEDIA, BASE (July 3, 1986)
  • K862392 — BIOTIS MOTILITY TEST MEDIUM (July 3, 1986)
  • K862389 — BIOTIS ACETAMIDE AGAR (July 3, 1986)

Other clearances for product code JSG

  • K882495 — THIOGLYCOLLATE BROTH W/VITA. K & HEMIN - #T3007 (July 1, 1988)
  • K881548 — MPH AGAR (April 18, 1988)
  • K881554 — SKIM MILK DEHYDRATED (April 18, 1988)
  • K881542 — HEART INFUSION AGAR (April 18, 1988)
  • K881563 — TRYPTOSE PHOSPHATE BROTH (April 18, 1988)
  • K881523 — DEXTROSE TRYPTONE BROTH (April 18, 1988)
  • K881543 — LETHEEN AGAR (April 18, 1988)
  • K881528 — CASEIN PEPTONE, LOW VITAMIN (April 18, 1988)
  • K881531 — BLOOD AGAR BASE, IMPROVED (April 18, 1988)
  • K881525 — COOKED MEAT MEDIUM (April 18, 1988)