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510(k) K871095

CLED AGAR by bioMerieux, Inc. — Product Code JSH

K871095 is an FDA 510(k) premarket notification submitted by bioMerieux, Inc. for the device "CLED AGAR". The FDA issued a decision of Substantially Equivalent on April 3, 1987. The device falls under product code JSH (Culture Media, Non-Selective And Differential), a Class I device regulated under 21 CFR 866.2320. bioMerieux, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 3, 1987
Date Received
March 18, 1987
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Culture Media, Non-Selective And Differential
Device Class
Class I
Regulation Number
866.2320
Review Panel
MI
Submission Type

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  • K251579 — VITEK 2 AST-Gram Negative Cefazolin (=<1-=>32 µg/mL) (August 21, 2025)
  • K250274 — ETEST Imipenem/Relebactam P. aeruginosa (IRPA) (0.008/4-128/4 µg/mL) (April 30, 2025)
  • K234012 — VITEK COMPACT PRO (March 14, 2025)
  • K232967 — VITEK 2 AST-Yeast Voriconazole (<= 0.03125 - >= 4 µg/mL) (June 12, 2024)
  • K232963 — VITEK 2 AST-Yeast Anidulafungin (<= 0.015 - >= 8 µg/mL) (June 7, 2024)
  • K240279 — VIDAS TBI (GFAP, UCH-L1) (May 1, 2024)
  • K234000 — VITEK 2 AST-Gram Positive Lefamulin (<=0.03 - >=4 µg/mL) (March 11, 2024)

Other clearances for product code JSH

  • K881559 — UREA AGAR BASE (April 18, 1988)
  • K881486 — DNASE TEST AGAR (April 18, 1988)
  • K881551 — PHENOL RED BROTH BASE (April 18, 1988)
  • K881560 — UREA BROTH (April 18, 1988)
  • K881553 — RUSSELL DOUBLE SUGAR AGAR (April 18, 1988)
  • K881540 — FLO AGAR (April 18, 1988)
  • K880121 — MOELLERS DECARBOXYLASE, BASE (March 31, 1988)
  • K880117 — OF MEDIUM BASE (March 30, 1988)
  • K873270 — ACTINOMYCETE DIFFERENTIAL MEDIA (November 4, 1987)
  • K873263 — MAINTENANCE & CARBOHYDRATE FERMENTATION MEDIA (October 28, 1987)

FDA data resources