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510(k) K841144

CHOCOLATE AGAR W/COFACTOR by Anaerobe Systems — Product Code JSG

K841144 is an FDA 510(k) premarket notification submitted by Anaerobe Systems for the device "CHOCOLATE AGAR W/COFACTOR". The FDA issued a decision of Substantially Equivalent on March 26, 1984. The device falls under product code JSG (Culture Media, Non-Selective And Non-Differential), a Class I device regulated under 21 CFR 866.2300. Anaerobe Systems has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 26, 1984
Date Received
March 16, 1984
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Culture Media, Non-Selective And Non-Differential
Device Class
Class I
Regulation Number
866.2300
Review Panel
MI
Submission Type

Other clearances by Anaerobe Systems

  • K844380 — BILE DIFFERENTIAL DISK (January 4, 1985)
  • K844382 — VANCOMYCIN 5MCG DIFFERENTIAL DISK (January 4, 1985)
  • K844381 — COLISTIN 10 MCG. DIFFERENTIAL DISK (January 4, 1985)
  • K844383 — KANAMYCIN 1000 MCG DIFFERENTIAL DISK (January 4, 1985)
  • K841303 — CAMPYLOBACTER THIOGLYCOLLATE MED (April 17, 1984)
  • K841218 — CYCLOSERINE-CEFOXITIN FRUCTOSE AGAR (April 5, 1984)
  • K841142 — LEVINE EOSIN METHYLENE BLUE AGAR (April 5, 1984)
  • K841220 — ANAEROBIC TRANSPORT MEDIUM (April 4, 1984)
  • K841222 — BACTEROIDES BILE ESCULIN GAR (April 4, 1984)
  • K841138 — MUELLER HINTON AGAR W/BLOOD & COFACTOR (April 4, 1984)

Other clearances for product code JSG

  • K882495 — THIOGLYCOLLATE BROTH W/VITA. K & HEMIN - #T3007 (July 1, 1988)
  • K881531 — BLOOD AGAR BASE, IMPROVED (April 18, 1988)
  • K881528 — CASEIN PEPTONE, LOW VITAMIN (April 18, 1988)
  • K881563 — TRYPTOSE PHOSPHATE BROTH (April 18, 1988)
  • K881548 — MPH AGAR (April 18, 1988)
  • K881542 — HEART INFUSION AGAR (April 18, 1988)
  • K881550 — OF BASAL MEDIUM (April 18, 1988)
  • K881558 — TRYPTOSE AGAR (April 18, 1988)
  • K881523 — DEXTROSE TRYPTONE BROTH (April 18, 1988)
  • K881541 — GELATIN (April 18, 1988)

FDA data resources