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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 Apr 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 2 other 510(k) clearances on record.

Clearance details

Decision
SESE (Substantially Equivalent)
Decision Date
Apr 13, 1984
Date Received
Mar 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
510(k) Exempt

Other clearances by Chatham Biological

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

Other clearances for product code JSD

  • K883075 — FASTIDIOUS INOCULUM BROTH (Aug 15, 1988)
  • K880107 — CAMPY BROTH (Mar 30, 1988)
  • K873324 — SABOURAUD DEXTROSE (SD) BROTH TUBE, #T3331 (Oct 2, 1987)
  • K873218 — BRAIN HEART INFUSION BROTH W/6.5% NAC1 - #T3802 (Sep 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 (Mar 30, 1987)
  • K853609 — APL TRYPTIC SOY BROTH (Sep 12, 1985)
  • K844547 — TRYPTIC SOY BROTH W/6.5%SODIUM CHLORIDE (Jan 16, 1985)
  • K841836 — SELECTIVE CULTURE MED. TRICHOMONAS (May 14, 1984)

FDA data resources

Source: FDA 510(k) database entry for K840971. Report a data issue: hello@regdatalab.com.