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510(k) K840971

SELECTIVE CULTURE MEDIUM by Chatham Biological — Product Code JSD

K840971 is an FDA 510(k) premarket notification submitted by Chatham Biological for the device "SELECTIVE CULTURE MEDIUM". The FDA issued a decision of Substantially Equivalent on April 13, 1984. The device falls under product code JSD (Culture Media, Selective Broth), a Class I device regulated under 21 CFR 866.2360. Chatham Biological has at least 2 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 13, 1984
Date Received
March 6, 1984
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Culture Media, Selective Broth
Device Class
Class I
Regulation Number
866.2360
Review Panel
MI
Submission Type

Other clearances by Chatham Biological

  • K840970 — CULTURE MEDIUM FOR PATHOGENIC NEISSER (April 13, 1984)
  • K840969 — CULTURE MEDIA FOR ANTIMICROBIAL SUSCEP (April 13, 1984)

Other clearances for product code JSD

  • K883075 — FASTIDIOUS INOCULUM BROTH (August 15, 1988)
  • K880107 — CAMPY BROTH (March 30, 1988)
  • K873324 — SABOURAUD DEXTROSE (SD) BROTH TUBE, #T3331 (October 2, 1987)
  • K873218 — BRAIN HEART INFUSION BROTH W/6.5% NAC1 - #T3802 (September 23, 1987)
  • K871640 — ALKALINE PEPTONE WATER (May 13, 1987)
  • K871447 — TODD HEWITT W/CNA (LIM BROTH) (May 13, 1987)
  • K870594 — T9802 TSB W/6.5% NACL (March 30, 1987)
  • K853609 — APL TRYPTIC SOY BROTH (September 12, 1985)
  • K844547 — TRYPTIC SOY BROTH W/6.5%SODIUM CHLORIDE (January 16, 1985)
  • K841836 — SELECTIVE CULTURE MED. TRICHOMONAS (May 14, 1984)

FDA data resources