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510(k) K801847

TRIPLE SUGAR IRON AGAR(MICRO/CULT/MEDIA by Radiation Technology, Inc. — Product Code JSH

K801847 is an FDA 510(k) premarket notification submitted by Radiation Technology, Inc. for the device "TRIPLE SUGAR IRON AGAR(MICRO/CULT/MEDIA". The FDA issued a decision of Substantially Equivalent on August 13, 1980. The device falls under product code JSH (Culture Media, Non-Selective And Differential), a Class I device regulated under 21 CFR 866.2320. Radiation Technology, Inc. has at least 6 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 13, 1980
Date Received
August 4, 1980
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Culture Media, Non-Selective And Differential
Device Class
Class I
Regulation Number
866.2320
Review Panel
MI
Submission Type

Other clearances by Radiation Technology, Inc.

  • K910648 — THERAPY CHAIR SYSTEM (July 22, 1991)
  • K802892 — CULTURE MEDIA FOR IN VITRO DIAG. USE (December 11, 1980)
  • K801943 — BRAIN HEART INFUSION MICROBIOLOGICAL (September 9, 1980)
  • K801817 — MICROBIOLOGY CULTURE MEDIA, C.L.E.D. (August 27, 1980)
  • K801901 — MUELLER HINTON AGAR (August 20, 1980)
  • K801772 — MICROBIOLOGY CULTURE MEDIA-MACCONKEY AG (August 20, 1980)

Other clearances for product code JSH

  • K881559 — UREA AGAR BASE (April 18, 1988)
  • K881560 — UREA BROTH (April 18, 1988)
  • K881551 — PHENOL RED BROTH BASE (April 18, 1988)
  • K881540 — FLO AGAR (April 18, 1988)
  • K881486 — DNASE TEST AGAR (April 18, 1988)
  • K881553 — RUSSELL DOUBLE SUGAR AGAR (April 18, 1988)
  • K880121 — MOELLERS DECARBOXYLASE, BASE (March 31, 1988)
  • K880117 — OF MEDIUM BASE (March 30, 1988)
  • K873270 — ACTINOMYCETE DIFFERENTIAL MEDIA (November 4, 1987)
  • K873263 — MAINTENANCE & CARBOHYDRATE FERMENTATION MEDIA (October 28, 1987)

FDA data resources