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510(k) K873263

MAINTENANCE & CARBOHYDRATE FERMENTATION MEDIA by Central Media — Product Code JSH

K873263 is an FDA 510(k) premarket notification submitted by Central Media for the device "MAINTENANCE & CARBOHYDRATE FERMENTATION MEDIA". The FDA issued a decision of Substantially Equivalent on October 28, 1987. The device falls under product code JSH (Culture Media, Non-Selective And Differential), a Class I device regulated under 21 CFR 866.2320. Central Media has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 28, 1987
Date Received
August 11, 1987
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Culture Media, Non-Selective And Differential
Device Class
Class I
Regulation Number
866.2320
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)
  • K873259 — SPECIALTY 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)
  • K873266 — MIDDLEBROOK BASED MEDIA (October 28, 1987)
  • K873264 — MEDIA FOR DETECTION & VERIFICATION OF COLIFORMS (October 28, 1987)

Other clearances for product code JSH

  • K881553 — RUSSELL DOUBLE SUGAR AGAR (April 18, 1988)
  • K881540 — FLO AGAR (April 18, 1988)
  • K881560 — UREA BROTH (April 18, 1988)
  • K881559 — UREA AGAR BASE (April 18, 1988)
  • K881486 — DNASE TEST AGAR (April 18, 1988)
  • K881551 — PHENOL RED BROTH BASE (April 18, 1988)
  • K880121 — MOELLERS DECARBOXYLASE, BASE (March 31, 1988)
  • K880117 — OF MEDIUM BASE (March 30, 1988)
  • K873270 — ACTINOMYCETE DIFFERENTIAL MEDIA (November 4, 1987)
  • K873411 — SIMMONS CITRATE MEDIUM SLANT, PRODUCT #T3084 (October 6, 1987)

FDA data resources