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510(k) K874177

BIOTIS (TM) BCYE by Otisville Biopharm, Inc. — Product Code KZI

K874177 is an FDA 510(k) premarket notification submitted by Otisville Biopharm, Inc. for the device "BIOTIS (TM) BCYE". The FDA issued a decision of Substantially Equivalent on December 4, 1987. The device falls under product code KZI (Culture Media, Enriched), a Class I device regulated under 21 CFR 866.2330. 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 15, 1987
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Culture Media, Enriched
Device Class
Class I
Regulation Number
866.2330
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)
  • 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 KZI

  • K884208 — LISTERIA SELECTIVE MEDIUM (OXFORD FORMULATION) (October 25, 1988)
  • K881995 — DIAMOND'S MEDIUM MODIFIED (June 2, 1988)
  • K880122 — MIDDLEBROOK 7H9 BROTH (March 31, 1988)
  • K880134 — MIDDLEBROOK 7H11 AGAR (March 31, 1988)
  • K880131 — LOWENSTEIN-JENSEN, GRUFT (March 31, 1988)
  • K880109 — CYSTINE TRYPTIC MEDIUM BASE (March 30, 1988)
  • K880138 — WALLENSTEIN MEDIUM SLANT (March 30, 1988)
  • K880127 — POTATO DEXTROSE AGAR (March 7, 1988)
  • K874179 — BIOTIS (TM) SABHI (DOUBLE POUR) (January 28, 1988)
  • K873267 — ECG BASED MEDIA (November 4, 1987)

FDA data resources