Home / 510(k) Clearances / K851275

510(k) K851275

GIBCO MYCOTECT 189-5670 by Gibco Laboratories Life Technologies, Inc. — Product Code KIW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 21, 1985
Date Received
April 1, 1985
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Kit, Mycoplasma Detection
Device Class
Class I
Regulation Number
864.2360
Review Panel
PA
Submission Type

Other clearances by Gibco Laboratories Life Technologies, Inc.

  • K871855 — SORBITOL MACCONKEY (SMAC) AGAR, DRI & PRE-FORM (May 26, 1987)
  • K871541 — MARTIN-LEWIS AGAR W/REDUCED VANCOMYCIN C0226 (April 29, 1987)
  • K870134 — MCBRIDE LISTERIA AGAR W/CYCLOHEXIMIDE, DRI & PRE (February 4, 1987)
  • K864755 — PSEUDOMONAS CEPACIA SELECTIVE AGAR, DRI & PRE-FORM (January 5, 1987)
  • K864014 — LOMBARD DOWELL AGAR BASE (October 29, 1986)
  • K863821 — MUELLER HINTON AGAR W/4%NACL AND OXACILLIN (October 9, 1986)
  • K863820 — DRI-FORM: GBNA LISTERIA MEDIUM NO. M22300 (October 8, 1986)
  • K863289 — CDC ANAEROBIC AGAR W/SHEEP BLOOD, KANA-&VANCOMYCIN (September 3, 1986)
  • K862425 — MACCONKEY AGAR W/MUG, DRI-FORM AND PRE-FORM (July 2, 1986)
  • K861058 — SENSITITRE AUTO ID PLATE, AP70 (May 20, 1986)

Other clearances for product code KIW

  • K860695 — GIBCO MYCOTECT KIT (CATALOG NO. 189-5672) (March 12, 1986)