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510(k) K860416

BIOTIS REGAN-LOWE by Otisville Biotech, Inc. — Product Code JSJ

K860416 is an FDA 510(k) premarket notification submitted by Otisville Biotech, Inc. for the device "BIOTIS REGAN-LOWE". The FDA issued a decision of Substantially Equivalent on February 24, 1986. The device falls under product code JSJ (Culture Media, Selective And Non-Differential), a Class I device regulated under 21 CFR 866.2360. Otisville Biotech, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 24, 1986
Date Received
February 3, 1986
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 Biotech, Inc.

  • K862393 — BIOTIS LITMUS MILK (July 3, 1986)
  • K862389 — BIOTIS ACETAMIDE AGAR (July 3, 1986)
  • K862392 — BIOTIS MOTILITY TEST MEDIUM (July 3, 1986)
  • K862396 — BIOTIS DECARBOXYLASE MEDIA, ARGININE (July 3, 1986)
  • K862400 — BIOTIS KV LAKED BLOOD AGAR (July 3, 1986)
  • K862390 — BIOTIS BORDET GENGOU AGAR (July 3, 1986)
  • K862388 — BIOTIS TCBS AGAR (July 3, 1986)
  • K862387 — BIOTIS HAEMOPHILUS IDENTIFICATION QUAD (July 3, 1986)
  • K862391 — BIOTIS DESOXYCHOLATE AGAR (July 3, 1986)
  • K862398 — BIOTIS DECARBOXYLASE MEDIA, ORNITHINE (July 3, 1986)

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