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510(k) K860409

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

K860409 is an FDA 510(k) premarket notification submitted by Otisville Biotech, Inc. for the device "BIOTIS COLUMBIA SHEEP BLOOD AGAR". The FDA issued a decision of Substantially Equivalent on February 24, 1986. The device falls under product code JSG (Culture Media, Non-Selective And Non-Differential), a Class I device regulated under 21 CFR 866.2300. Otisville Biotech, Inc. has at least 10 other 510(k) clearances on record.

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.

  • K862393 — BIOTIS LITMUS MILK (July 3, 1986)
  • K862389 — BIOTIS ACETAMIDE AGAR (July 3, 1986)
  • K862391 — BIOTIS DESOXYCHOLATE AGAR (July 3, 1986)
  • K862396 — BIOTIS DECARBOXYLASE MEDIA, ARGININE (July 3, 1986)
  • K862387 — BIOTIS HAEMOPHILUS IDENTIFICATION QUAD (July 3, 1986)
  • K862390 — BIOTIS BORDET GENGOU AGAR (July 3, 1986)
  • K862388 — BIOTIS TCBS AGAR (July 3, 1986)
  • K862392 — BIOTIS MOTILITY TEST MEDIUM (July 3, 1986)
  • K862400 — BIOTIS KV LAKED BLOOD AGAR (July 3, 1986)
  • K862398 — BIOTIS DECARBOXYLASE MEDIA, ORNITHINE (July 3, 1986)

Other clearances for product code JSG

  • K882495 — THIOGLYCOLLATE BROTH W/VITA. K & HEMIN - #T3007 (July 1, 1988)
  • K881563 — TRYPTOSE PHOSPHATE BROTH (April 18, 1988)
  • K881554 — SKIM MILK DEHYDRATED (April 18, 1988)
  • K881541 — GELATIN (April 18, 1988)
  • K881528 — CASEIN PEPTONE, LOW VITAMIN (April 18, 1988)
  • K881542 — HEART INFUSION AGAR (April 18, 1988)
  • K881531 — BLOOD AGAR BASE, IMPROVED (April 18, 1988)
  • K881548 — MPH AGAR (April 18, 1988)
  • K881523 — DEXTROSE TRYPTONE BROTH (April 18, 1988)
  • K881550 — OF BASAL MEDIUM (April 18, 1988)

FDA data resources