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510(k) K801817

MICROBIOLOGY CULTURE MEDIA, C.L.E.D. by Radiation Technology, Inc. — Product Code JSH

K801817 is an FDA 510(k) premarket notification submitted by Radiation Technology, Inc. for the device "MICROBIOLOGY CULTURE MEDIA, C.L.E.D.". The FDA issued a decision of Substantially Equivalent on August 27, 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 27, 1980
Date Received
July 31, 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)
  • K801901 — MUELLER HINTON AGAR (August 20, 1980)
  • K801772 — MICROBIOLOGY CULTURE MEDIA-MACCONKEY AG (August 20, 1980)
  • K801847 — TRIPLE SUGAR IRON AGAR(MICRO/CULT/MEDIA (August 13, 1980)

Other clearances for product code JSH

  • K881551 — PHENOL RED BROTH BASE (April 18, 1988)
  • K881486 — DNASE TEST AGAR (April 18, 1988)
  • K881553 — RUSSELL DOUBLE SUGAR AGAR (April 18, 1988)
  • K881559 — UREA AGAR BASE (April 18, 1988)
  • K881540 — FLO AGAR (April 18, 1988)
  • K881560 — UREA BROTH (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