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510(k) K870502

CULTURIA MACCONKEY-MUG/MODIFIED TSA SYSTEMS by Clinical Convenience Products, Inc. — Product Code JSI

K870502 is an FDA 510(k) premarket notification submitted by Clinical Convenience Products, Inc. for the device "CULTURIA MACCONKEY-MUG/MODIFIED TSA SYSTEMS". The FDA issued a decision of Substantially Equivalent on February 26, 1987. The device falls under product code JSI (Culture Media, Selective And Differential), a Class I device regulated under 21 CFR 866.2360. Clinical Convenience Products, Inc. has at least 5 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 26, 1987
Date Received
February 4, 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 Clinical Convenience Products, Inc.

  • K934759 — CULTURIA MACCONKEY-MUG (September 9, 1994)
  • K864764 — CULTURIA MACCONKEY-MUG/CLED SYSTEMS (December 29, 1986)
  • K800215 — CULTURIA MACCONKEY/CLED #DM87 (February 13, 1980)
  • K792579 — CULTURIA MACCONKEY/COLUMBIA CNA (January 11, 1980)
  • K792284 — CULTURIA EMB/COLUMBIA CNA W/5% SHEEP (December 19, 1979)

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