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510(k) K842853

LYSINE IRON AGAR by Anarobe Systems — Product Code JSF

K842853 is an FDA 510(k) premarket notification submitted by Anarobe Systems for the device "LYSINE IRON AGAR". The FDA issued a decision of Substantially Equivalent on August 3, 1984. The device falls under product code JSF (Culture Media, Single Biochemical Test), a Class I device regulated under 21 CFR 866.2320. 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, Single Biochemical Test
Device Class
Class I
Regulation Number
866.2320
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)
  • K842852 — BRAIN HEART INFUSION BROTH (August 3, 1984)
  • K842849 — TRYPTICASE SOY BROTH (August 3, 1984)
  • K842855 — CHRISTENSEN'S UREA AGAR (August 3, 1984)

Other clearances for product code JSF

  • K880946 — NUTRIENT GELATIN - PRODUCT NUMBER T2860 (April 1, 1988)
  • K880119 — MOELLERS DECARBOXYLASE, ONITHINE (March 31, 1988)
  • K880120 — MOELLERS DECARBOXYLASE, LYSINE (March 31, 1988)
  • K880126 — LAURYL TRYPTOSE BROTH (March 31, 1988)
  • K880112 — CYSTINE TRYPTIC MEDIUM W/ MALTOSE (March 30, 1988)
  • K880113 — CYSTINE TRYPTIC MEDIUM W/LACTOSE (March 30, 1988)
  • K880110 — CYSTINE TRYPTIC MEDIUM W/DEXTROSE (March 30, 1988)
  • K880129 — BRILLIANT GREEN BILE BROTH (March 30, 1988)
  • K880139 — ONPG TEST REAGENT (March 30, 1988)
  • K880135 — NITRATE BROTH (March 30, 1988)

FDA data resources