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510(k) K873259

SPECIALTY MEDIA by Central Media — Product Code JSI

K873259 is an FDA 510(k) premarket notification submitted by Central Media for the device "SPECIALTY MEDIA". The FDA issued a decision of Substantially Equivalent on November 6, 1987. The device falls under product code JSI (Culture Media, Selective And Differential), a Class I device regulated under 21 CFR 866.2360. Central Media has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 6, 1987
Date Received
August 11, 1987
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Culture Media, Selective And Differential
Device Class
Class I
Regulation Number
866.2360
Review Panel
MI
Submission Type

Other clearances by Central Media

  • K873260 — CORYNEBACTERIA ISOLATION MEDIA (November 6, 1987)
  • K873257 — GENERAL PURPOSE MEDIA W/SELECT. & DIFF. MODIFICA. (November 6, 1987)
  • K873258 — STREPTOCOCCAL SELECTIVE DIFFEREN. & ENRICHED MEDIA (November 6, 1987)
  • K873268 — MUELLER HINTON MEDIA (November 4, 1987)
  • K873267 — ECG BASED MEDIA (November 4, 1987)
  • K873269 — MYCOLOGICAL MEDIA (November 4, 1987)
  • K873270 — ACTINOMYCETE DIFFERENTIAL MEDIA (November 4, 1987)
  • K873262 — DIFFERENTIAL MEDIA (October 28, 1987)
  • K873266 — MIDDLEBROOK BASED MEDIA (October 28, 1987)
  • K873264 — MEDIA FOR DETECTION & VERIFICATION OF COLIFORMS (October 28, 1987)

Other clearances for product code JSI

  • K070691 — BBL CHROMAGAR 0157 (November 20, 2007)
  • K974428 — DIPSTREAK (July 30, 1998)
  • K891593 — LISTERIA SELECTIVE ENRICHMENT MEDIUM (June 9, 1989)
  • K890199 — DENTOCULT SM-STRIP MUTANS (March 2, 1989)
  • K882182 — SALMONELLA-SHIGELLA (SS) AGAR - PRODUCT #P3326 (June 6, 1988)
  • K881572 — XL AGAR BASE (April 18, 1988)
  • K881576 — SELENITE BROTH (April 18, 1988)
  • K881575 — SELECTIVE STREPTOCOCCUS AGAR (April 18, 1988)
  • K881555 — TINSDALE AGAR BASE (April 18, 1988)
  • K881577 — MODIFIED SELECTIVE STREPTOCOCCUS AGAR (April 18, 1988)

FDA data resources