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510(k) K820214

SUCROSE by Dms Laboratories — Product Code JSE

K820214 is an FDA 510(k) premarket notification submitted by Dms Laboratories for the device "SUCROSE". The FDA issued a decision of Substantially Equivalent on February 5, 1982. The device falls under product code JSE (Culture Media, Multiple Biochemical Test), a Class I device regulated under 21 CFR 866.2320. Dms Laboratories has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 5, 1982
Date Received
January 26, 1982
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Culture Media, Multiple Biochemical Test
Device Class
Class I
Regulation Number
866.2320
Review Panel
MI
Submission Type

Other clearances by Dms Laboratories

  • K831187 — TRP (May 9, 1983)
  • K831186 — RAPID NFT (May 9, 1983)
  • K830437 — CHS (March 17, 1983)
  • K823102 — AGAR P (December 3, 1982)
  • K821038 — FAST VIOLET B (May 27, 1982)
  • K813612 — RAPID ZYME (February 22, 1982)
  • K813613 — RAPID CH (February 22, 1982)
  • K820213 — SALINE SOLUTION (February 12, 1982)
  • K820211 — NINHYDRIN (February 12, 1982)
  • K820210 — IND (February 12, 1982)

Other clearances for product code JSE

  • K962265 — MLX MICROTITER PLATE LUMINOMETER (July 25, 1996)
  • K883996 — X-ACT LDC/IND (October 12, 1988)
  • K883995 — X-ACT UREA/TDA (October 12, 1988)
  • K880133 — MIL MEDIUM (March 31, 1988)
  • K880116 — MRVP BROTH (March 31, 1988)
  • K874537 — KLIGLER IRON AGAR AND TRIPLE SUGAR IRON AGAR (November 20, 1987)
  • K871096 — CYSTINE TRYPTIC AGAR W/O CARBOHYDRATES (April 3, 1987)
  • K864674 — MICRODILUTION IDENTIFICATION PANELS (January 5, 1987)
  • K862393 — BIOTIS LITMUS MILK (July 3, 1986)
  • K860412 — BIOTIS SIM MEDIUM (February 24, 1986)

FDA data resources