Home / 510(k) Clearances / K974428

510(k) K974428

DIPSTREAK by Novamed , Ltd. — Product Code JSI

K974428 is an FDA 510(k) premarket notification submitted by Novamed , Ltd. for the device "DIPSTREAK". The FDA issued a decision of Substantially Equivalent on July 30, 1998. The device falls under product code JSI (Culture Media, Selective And Differential), a Class I device regulated under 21 CFR 866.2360. Novamed , Ltd. has at least 3 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 30, 1998
Date Received
November 24, 1997
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 Novamed , Ltd.

  • K063477 — NOVAMED MRI CONDITIONAL LARYNGOSCOPE SET (February 9, 2007)
  • K062020 — LIFESOUND ESOPHAGEAL STETHOSCOPE (September 5, 2006)
  • K000718 — CHROMOSTREAK (August 24, 2000)

Other clearances for product code JSI

  • K070691 — BBL CHROMAGAR 0157 (November 20, 2007)
  • 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)
  • K881555 — TINSDALE AGAR BASE (April 18, 1988)
  • K881575 — SELECTIVE STREPTOCOCCUS AGAR (April 18, 1988)
  • K881576 — SELENITE BROTH (April 18, 1988)
  • K881577 — MODIFIED SELECTIVE STREPTOCOCCUS AGAR (April 18, 1988)
  • K881556 — TRICHOMONAS BROTH (April 18, 1988)

FDA data resources