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510(k) K873267

ECG BASED MEDIA by Central Media — Product Code KZI

K873267 is an FDA 510(k) premarket notification submitted by Central Media for the device "ECG BASED MEDIA". The FDA issued a decision of Substantially Equivalent on November 4, 1987. The device falls under product code KZI (Culture Media, Enriched), a Class I device regulated under 21 CFR 866.2330. Central Media has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 4, 1987
Date Received
August 11, 1987
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Culture Media, Enriched
Device Class
Class I
Regulation Number
866.2330
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)
  • 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)
  • K873263 — MAINTENANCE & CARBOHYDRATE FERMENTATION MEDIA (October 28, 1987)

Other clearances for product code KZI

  • K884208 — LISTERIA SELECTIVE MEDIUM (OXFORD FORMULATION) (October 25, 1988)
  • K881995 — DIAMOND'S MEDIUM MODIFIED (June 2, 1988)
  • K880122 — MIDDLEBROOK 7H9 BROTH (March 31, 1988)
  • K880131 — LOWENSTEIN-JENSEN, GRUFT (March 31, 1988)
  • K880134 — MIDDLEBROOK 7H11 AGAR (March 31, 1988)
  • K880109 — CYSTINE TRYPTIC MEDIUM BASE (March 30, 1988)
  • K880138 — WALLENSTEIN MEDIUM SLANT (March 30, 1988)
  • K880127 — POTATO DEXTROSE AGAR (March 7, 1988)
  • K874179 — BIOTIS (TM) SABHI (DOUBLE POUR) (January 28, 1988)
  • K874177 — BIOTIS (TM) BCYE (December 4, 1987)

FDA data resources