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510(k) K874176

BIOTIS (TM) HAEMOPHILUS DUCREYI by Otisville Biopharm, Inc. — Product Code JSJ

K874176 is an FDA 510(k) premarket notification submitted by Otisville Biopharm, Inc. for the device "BIOTIS (TM) HAEMOPHILUS DUCREYI". The FDA issued a decision of Substantially Equivalent on February 5, 1988. The device falls under product code JSJ (Culture Media, Selective And Non-Differential), a Class I device regulated under 21 CFR 866.2360. Otisville Biopharm, Inc. has at least 7 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 5, 1988
Date Received
October 13, 1987
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

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

Other clearances by Otisville Biopharm, Inc.

  • K874179 — BIOTIS (TM) SABHI (DOUBLE POUR) (January 28, 1988)
  • K874177 — BIOTIS (TM) BCYE (December 4, 1987)
  • K874175 — BIOTIS (TM) MUELLER HINTON W/4% SALT, 6MCG/ML OXAC (December 4, 1987)
  • K874174 — BIOTIS (TM) STARCH HYDROLYSIS WITH BCP (December 4, 1987)
  • K874178 — BIOTIS (TM) BCYE SELECTIVE (December 4, 1987)
  • K874173 — BIOTIS (TM) BHI WITH HRBC, CHLORA/GENTAM/CYCLOHEXI (October 28, 1987)
  • K874172 — BIOTIS (TM) INHIBITORY MOLD AGAR (DOUBLE POUR) (October 28, 1987)

Other clearances for product code JSJ

  • K882463 — POTATO DEXTROSE AGAR (PDA) - PRODUCT #P3421 (June 22, 1988)
  • K881544 — LITTMAN AGAR (April 18, 1988)
  • K881524 — DERMATOPHYTE TEST MEDIUM (April 18, 1988)
  • K881571 — YM BROTH (April 18, 1988)
  • K881573 — PHYTONE YEAST EXTRACT AGAR (April 18, 1988)
  • K881578 — STREPTOSEL (April 18, 1988)
  • K881561 — TERGITOL 7 BROTH (April 18, 1988)
  • K881526 — CHAPMAN STONE MEDIUM (April 18, 1988)
  • K881565 — INHIBITORY MOLD AGAR (April 18, 1988)
  • K881547 — MITIS SALIVARIUS AGAR (April 18, 1988)

FDA data resources