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510(k) K862397

BIOTIS DECARBOXYLASE MEDIA, LYSINE by Otisville Biotech, Inc. — Product Code JSF

K862397 is an FDA 510(k) premarket notification submitted by Otisville Biotech, Inc. for the device "BIOTIS DECARBOXYLASE MEDIA, LYSINE". The FDA issued a decision of Substantially Equivalent on Jul 3, 1986. The device falls under product code JSF (Culture Media, Single Biochemical Test), a Class I device regulated under 21 CFR 866.2320. Otisville Biotech, Inc. has 97 other 510(k) clearances on record.

Clearance details

Decision
SESE (Substantially Equivalent)
Decision Date
Jul 3, 1986
Date Received
Jun 24, 1986
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
510(k) Exempt

Other clearances by Otisville Biotech, Inc.

  • K862388 — BIOTIS TCBS AGAR (Jul 3, 1986)
  • K862393 — BIOTIS LITMUS MILK (Jul 3, 1986)
  • K862396 — BIOTIS DECARBOXYLASE MEDIA, ARGININE (Jul 3, 1986)
  • K862400 — BIOTIS KV LAKED BLOOD AGAR (Jul 3, 1986)
  • K862387 — BIOTIS HAEMOPHILUS IDENTIFICATION QUAD (Jul 3, 1986)
  • K862398 — BIOTIS DECARBOXYLASE MEDIA, ORNITHINE (Jul 3, 1986)
  • K862390 — BIOTIS BORDET GENGOU AGAR (Jul 3, 1986)
  • K862389 — BIOTIS ACETAMIDE AGAR (Jul 3, 1986)
  • K862395 — BIOTIS DECARBOXYLASE MEDIA, BASE (Jul 3, 1986)
  • K862392 — BIOTIS MOTILITY TEST MEDIUM (Jul 3, 1986)

Other clearances for product code JSF

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

FDA data resources

Source: FDA 510(k) database entry for K862397. Report a data issue: hello@regdatalab.com.