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510(k) K862387

BIOTIS HAEMOPHILUS IDENTIFICATION QUAD by Otisville Biotech, Inc. — Product Code JSH

K862387 is an FDA 510(k) premarket notification submitted by Otisville Biotech, Inc. for the device "BIOTIS HAEMOPHILUS IDENTIFICATION QUAD". The FDA issued a decision of Substantially Equivalent on July 3, 1986. The device falls under product code JSH (Culture Media, Non-Selective And Differential), a Class I device regulated under 21 CFR 866.2320. Otisville Biotech, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

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

Device Classification

Device Name
Culture Media, Non-Selective And Differential
Device Class
Class I
Regulation Number
866.2320
Review Panel
MI
Submission Type

Other clearances by Otisville Biotech, Inc.

  • K862390 — BIOTIS BORDET GENGOU AGAR (July 3, 1986)
  • K862398 — BIOTIS DECARBOXYLASE MEDIA, ORNITHINE (July 3, 1986)
  • K862391 — BIOTIS DESOXYCHOLATE AGAR (July 3, 1986)
  • K862393 — BIOTIS LITMUS MILK (July 3, 1986)
  • K862400 — BIOTIS KV LAKED BLOOD AGAR (July 3, 1986)
  • K862389 — BIOTIS ACETAMIDE AGAR (July 3, 1986)
  • K862388 — BIOTIS TCBS AGAR (July 3, 1986)
  • K862392 — BIOTIS MOTILITY TEST MEDIUM (July 3, 1986)
  • K862396 — BIOTIS DECARBOXYLASE MEDIA, ARGININE (July 3, 1986)
  • K862395 — BIOTIS DECARBOXYLASE MEDIA, BASE (July 3, 1986)

Other clearances for product code JSH

  • K881551 — PHENOL RED BROTH BASE (April 18, 1988)
  • K881486 — DNASE TEST AGAR (April 18, 1988)
  • K881553 — RUSSELL DOUBLE SUGAR AGAR (April 18, 1988)
  • K881559 — UREA AGAR BASE (April 18, 1988)
  • K881540 — FLO AGAR (April 18, 1988)
  • K881560 — UREA BROTH (April 18, 1988)
  • K880121 — MOELLERS DECARBOXYLASE, BASE (March 31, 1988)
  • K880117 — OF MEDIUM BASE (March 30, 1988)
  • K873270 — ACTINOMYCETE DIFFERENTIAL MEDIA (November 4, 1987)
  • K873263 — MAINTENANCE & CARBOHYDRATE FERMENTATION MEDIA (October 28, 1987)

FDA data resources