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510(k) K822736

MYCOTRIUM-GU by Hana Biologics, Inc. — Product Code JSI

K822736 is an FDA 510(k) premarket notification submitted by Hana Biologics, Inc. for the device "MYCOTRIUM-GU". The FDA issued a decision of Substantially Equivalent on December 3, 1982. The device falls under product code JSI (Culture Media, Selective And Differential), a Class I device regulated under 21 CFR 866.2360. Hana Biologics, Inc. has at least 7 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 3, 1982
Date Received
September 9, 1982
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 Hana Biologics, Inc.

  • K883682 — CHANG MEDIUM (ADDITIONAL INDICATIONS) (September 16, 1988)
  • K855205 — MYCOTRIM TM VL TRIPHASIC CULTURE SYSTEM (February 5, 1986)
  • K834616 — AMNIO STAT-FLM AGGLUTINATION TEST (May 25, 1984)
  • K833933 — ACE COLOR TEST (March 23, 1984)
  • K822737 — MYCOTRIUM-RS (December 3, 1982)
  • K822150 — AMNISTAT-FLM (October 21, 1982)
  • K812820 — CHANG MEDIUM (November 10, 1981)

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