Home / 510(k) Clearances / K871640

510(k) K871640

ALKALINE PEPTONE WATER by Bd Becton Dickinson Vacutainer Systems Preanalytic — Product Code JSD

K871640 is an FDA 510(k) premarket notification submitted by Bd Becton Dickinson Vacutainer Systems Preanalytic for the device "ALKALINE PEPTONE WATER". The FDA issued a decision of Substantially Equivalent on May 13, 1987. The device falls under product code JSD (Culture Media, Selective Broth), a Class I device regulated under 21 CFR 866.2360. Bd Becton Dickinson Vacutainer Systems Preanalytic has 631 other 510(k) clearances on record.

Clearance details

Decision
SESE (Substantially Equivalent)
Decision Date
May 13, 1987
Date Received
Apr 27, 1987
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 Bd Becton Dickinson Vacutainer Systems Preanalytic

  • K003062 — BACTEC MGIT 960 SIR KITS (Jun 6, 2001)
  • K003553 — 0.9% SODIUM CHLORIDE INJECTION, USP BD PRE-FILLED FLUSH SYRINGE (Mar 21, 2001)
  • K003461 — BD VACUTAINER PASSIVE SHIELDING BLOOD COLLECTION NEEDLE (Feb 1, 2001)
  • K002938 — B-D ULTRA-FINE III PEN NEEDLE; MODEL 31G X 3/16 (Nov 29, 2000)
  • K001364 — BD DIRECTIGEN FLU A+B (Jun 28, 2000)
  • K000762 — MOXIFLOXACIN, 5 UG, BBL SENSI-DISC (Apr 25, 2000)
  • K000829 — GATIFLOXACIN, 5 UG, BBL SENSI-DISC (Apr 13, 2000)
  • K993186 — SYNERCID, 15 UG, BBL SENSI-DISC (Nov 3, 1999)
  • K992734 — BECTON DICKINSON SYRINGE (Oct 1, 1999)
  • K992849 — QBC STAR CENTRIFUGAL HEMATOLOGY SYSTEM (Sep 23, 1999)

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)
  • 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)
  • K840971 — SELECTIVE CULTURE MEDIUM (Apr 13, 1984)

FDA data resources

Source: FDA 510(k) database entry for K871640. Report a data issue: hello@regdatalab.com.