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510(k) K833759

GROUP STREP BROTH T3472 LIM by Gibco Laboratories Life Technologies, Inc. — Product Code JSD

K833759 is an FDA 510(k) premarket notification submitted by Gibco Laboratories Life Technologies, Inc. for the device "GROUP STREP BROTH T3472 LIM". The FDA issued a decision of Substantially Equivalent on Dec 16, 1983. The device falls under product code JSD (Culture Media, Selective Broth), a Class I device regulated under 21 CFR 866.2360. Gibco Laboratories Life Technologies, Inc. has 66 other 510(k) clearances on record.

Clearance details

Decision
SESE (Substantially Equivalent)
Decision Date
Dec 16, 1983
Date Received
Oct 26, 1983
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 Gibco Laboratories Life Technologies, Inc.

  • K871855 — SORBITOL MACCONKEY (SMAC) AGAR, DRI & PRE-FORM (May 26, 1987)
  • K871541 — MARTIN-LEWIS AGAR W/REDUCED VANCOMYCIN C0226 (Apr 29, 1987)
  • K870134 — MCBRIDE LISTERIA AGAR W/CYCLOHEXIMIDE, DRI & PRE (Feb 4, 1987)
  • K864755 — PSEUDOMONAS CEPACIA SELECTIVE AGAR, DRI & PRE-FORM (Jan 5, 1987)
  • K864014 — LOMBARD DOWELL AGAR BASE (Oct 29, 1986)
  • K863821 — MUELLER HINTON AGAR W/4%NACL AND OXACILLIN (Oct 9, 1986)
  • K863820 — DRI-FORM: GBNA LISTERIA MEDIUM NO. M22300 (Oct 8, 1986)
  • K863289 — CDC ANAEROBIC AGAR W/SHEEP BLOOD, KANA-&VANCOMYCIN (Sep 3, 1986)
  • K862425 — MACCONKEY AGAR W/MUG, DRI-FORM AND PRE-FORM (Jul 2, 1986)
  • K861058 — SENSITITRE AUTO ID PLATE, AP70 (May 20, 1986)

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 K833759. Report a data issue: hello@regdatalab.com.