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510(k) K820558

SELENITE BROTH by American Laboratory Supply, Inc. — Product Code JSD

K820558 is an FDA 510(k) premarket notification submitted by American Laboratory Supply, Inc. for the device "SELENITE BROTH". The FDA issued a decision of Substantially Equivalent on March 16, 1982. The device falls under product code JSD (Culture Media, Selective Broth), a Class I device regulated under 21 CFR 866.2360. American Laboratory Supply, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 16, 1982
Date Received
March 2, 1982
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 American Laboratory Supply, Inc.

  • K852578 — CLED AGAR (July 12, 1985)
  • K844932 — MALT AGAR (February 27, 1985)
  • K844929 — INHIBITORY MOLD AGAR (February 27, 1985)
  • K844931 — MYCOLOGICAL AGAR W/ANTIBIOTICS (February 27, 1985)
  • K844930 — BRILLANT GREEN AGAR (February 27, 1985)
  • K844933 — BILE ESCULIN AGAR (February 27, 1985)
  • K844934 — AZIDE AGAR W/5% SHEEP BLOOD (February 25, 1985)
  • K820550 — POTATO DEXTROSE AGAR (March 19, 1982)
  • K820562 — CAMPYLOBACTER SELECTIVE MEDIUM (March 19, 1982)
  • K820560 — PHENYLETHANOL AGAR W/5% SHEEP BLOOD (March 19, 1982)

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)
  • K871447 — TODD HEWITT W/CNA (LIM BROTH) (May 13, 1987)
  • K871640 — ALKALINE PEPTONE WATER (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