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510(k) K823102

AGAR P by Dms Laboratories — Product Code JSJ

K823102 is an FDA 510(k) premarket notification submitted by Dms Laboratories for the device "AGAR P". The FDA issued a decision of Substantially Equivalent on December 3, 1982. The device falls under product code JSJ (Culture Media, Selective And Non-Differential), a Class I device regulated under 21 CFR 866.2360. Dms Laboratories has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 3, 1982
Date Received
October 20, 1982
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Culture Media, Selective And Non-Differential
Device Class
Class I
Regulation Number
866.2360
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)
  • 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)
  • K820212 — OXI (February 12, 1982)

Other clearances for product code JSJ

  • K882463 — POTATO DEXTROSE AGAR (PDA) - PRODUCT #P3421 (June 22, 1988)
  • K881561 — TERGITOL 7 BROTH (April 18, 1988)
  • K881524 — DERMATOPHYTE TEST MEDIUM (April 18, 1988)
  • K881565 — INHIBITORY MOLD AGAR (April 18, 1988)
  • K881578 — STREPTOSEL (April 18, 1988)
  • K881573 — PHYTONE YEAST EXTRACT AGAR (April 18, 1988)
  • K881544 — LITTMAN AGAR (April 18, 1988)
  • K881526 — CHAPMAN STONE MEDIUM (April 18, 1988)
  • K881571 — YM BROTH (April 18, 1988)
  • K881547 — MITIS SALIVARIUS AGAR (April 18, 1988)

FDA data resources