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510(k) K842849

TRYPTICASE SOY BROTH by Anarobe Systems — Product Code JSC

K842849 is an FDA 510(k) premarket notification submitted by Anarobe Systems for the device "TRYPTICASE SOY BROTH". The FDA issued a decision of Substantially Equivalent on August 3, 1984. The device falls under product code JSC (Culture Media, General Nutrient Broth), a Class I device regulated under 21 CFR 866.2350. Anarobe Systems has at least 6 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 3, 1984
Date Received
July 20, 1984
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Culture Media, General Nutrient Broth
Device Class
Class I
Regulation Number
866.2350
Review Panel
MI
Submission Type

Other clearances by Anarobe Systems

  • K842850 — TRIPLE SUGAR IRON (August 17, 1984)
  • K842854 — MUELLER HINTON BROTH (August 17, 1984)
  • K842851 — ORNITHINE INDOLE MOTILITY (August 7, 1984)
  • K842853 — LYSINE IRON AGAR (August 3, 1984)
  • K842852 — BRAIN HEART INFUSION BROTH (August 3, 1984)
  • K842855 — CHRISTENSEN'S UREA AGAR (August 3, 1984)

Other clearances for product code JSC

  • K850143 — SPORDEX CULTURE MEDIA (March 5, 1985)
  • K842852 — BRAIN HEART INFUSION BROTH (August 3, 1984)
  • K841221 — BRAIN HEART INFUSION BROTH (April 4, 1984)
  • K841219 — SHOPPED MEAT CARBOHYDRATE (April 4, 1984)
  • K833300 — SABOURAUD BHI AGAR (November 7, 1983)
  • K832620 — TRYPTIC SOY BROTH MEDIA (September 12, 1983)
  • K832619 — THIOGLYCOLLATE MEDIUM (September 12, 1983)
  • K832570 — EXTRACT BROTH (September 12, 1983)
  • K832569 — INFUSION BROTH (September 12, 1983)
  • K830437 — CHS (March 17, 1983)

FDA data resources