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510(k) K874175

BIOTIS (TM) MUELLER HINTON W/4% SALT, 6MCG/ML OXAC by Otisville Biopharm, Inc. — Product Code JSF

K874175 is an FDA 510(k) premarket notification submitted by Otisville Biopharm, Inc. for the device "BIOTIS (TM) MUELLER HINTON W/4% SALT, 6MCG/ML OXAC". The FDA issued a decision of Substantially Equivalent on December 4, 1987. The device falls under product code JSF (Culture Media, Single Biochemical Test), a Class I device regulated under 21 CFR 866.2320. Otisville Biopharm, Inc. has at least 7 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 4, 1987
Date Received
October 13, 1987
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 Biopharm, Inc.

  • K874176 — BIOTIS (TM) HAEMOPHILUS DUCREYI (February 5, 1988)
  • K874179 — BIOTIS (TM) SABHI (DOUBLE POUR) (January 28, 1988)
  • K874177 — BIOTIS (TM) BCYE (December 4, 1987)
  • K874174 — BIOTIS (TM) STARCH HYDROLYSIS WITH BCP (December 4, 1987)
  • K874178 — BIOTIS (TM) BCYE SELECTIVE (December 4, 1987)
  • K874172 — BIOTIS (TM) INHIBITORY MOLD AGAR (DOUBLE POUR) (October 28, 1987)
  • K874173 — BIOTIS (TM) BHI WITH HRBC, CHLORA/GENTAM/CYCLOHEXI (October 28, 1987)

Other clearances for product code JSF

  • K880946 — NUTRIENT GELATIN - PRODUCT NUMBER T2860 (April 1, 1988)
  • K880126 — LAURYL TRYPTOSE BROTH (March 31, 1988)
  • K880119 — MOELLERS DECARBOXYLASE, ONITHINE (March 31, 1988)
  • K880120 — MOELLERS DECARBOXYLASE, LYSINE (March 31, 1988)
  • K880106 — ACETAMIDE AGAR SLANT (March 30, 1988)
  • K880112 — CYSTINE TRYPTIC MEDIUM W/ MALTOSE (March 30, 1988)
  • K880113 — CYSTINE TRYPTIC MEDIUM W/LACTOSE (March 30, 1988)
  • K880139 — ONPG TEST REAGENT (March 30, 1988)
  • K880129 — BRILLIANT GREEN BILE BROTH (March 30, 1988)
  • K880135 — NITRATE BROTH (March 30, 1988)

FDA data resources