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510(k) K770650

PRE-DUCED CULTURE MEDIA by Gibco Laboratories Life Technologies, Inc. — Product Code JSL

K770650 is an FDA 510(k) premarket notification submitted by Gibco Laboratories Life Technologies, Inc. for the device "PRE-DUCED CULTURE MEDIA". The FDA issued a decision of Substantially Equivalent on April 15, 1977. The device falls under product code JSL (Culture Media, Anaerobic Transport), a Class I device regulated under 21 CFR 866.2390. Gibco Laboratories Life Technologies, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 15, 1977
Date Received
April 6, 1977
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Culture Media, Anaerobic Transport
Device Class
Class I
Regulation Number
866.2390
Review Panel
MI
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 JSL

  • K972449 — COPAN VENTURI TRANSYSTEM AMIES MEDIUM WITH CHARCOAL (August 20, 1997)
  • K972448 — COPAN VENTURI TRANSYSTEM AMIES MEDIUM WITHOUT CHARCOAL (August 20, 1997)
  • K944847 — KULTSURE/STARSWAB ANAEROBIC TRANSPORT SYSTEM (February 16, 1995)
  • K925450 — BIONOR TRANSPORTMEDIUM (June 25, 1993)
  • K841220 — ANAEROBIC TRANSPORT MEDIUM (April 4, 1984)
  • K834357 — ANA TRANS TUBE & SWABS STERILE PACK (January 31, 1984)
  • K770840 — PRE-REDUCED ANAEROBIC MEDIA (June 8, 1977)

FDA data resources