Home / 510(k) Clearances / K801772

510(k) K801772

MICROBIOLOGY CULTURE MEDIA-MACCONKEY AG by Radiation Technology, Inc. — Product Code JJH

K801772 is an FDA 510(k) premarket notification submitted by Radiation Technology, Inc. for the device "MICROBIOLOGY CULTURE MEDIA-MACCONKEY AG". The FDA issued a decision of Substantially Equivalent on August 20, 1980. The device falls under product code JJH (Clinical Sample Concentrator), a Class I device regulated under 21 CFR 862.2310. Radiation Technology, Inc. has at least 6 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 20, 1980
Date Received
July 28, 1980
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Clinical Sample Concentrator
Device Class
Class I
Regulation Number
862.2310
Review Panel
CH
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)
  • K801847 — TRIPLE SUGAR IRON AGAR(MICRO/CULT/MEDIA (August 13, 1980)

Other clearances for product code JJH

  • K113731 — ESENSOR RESPIRATORY VIRAL PANEL (September 10, 2012)
  • K960298 — VIVASPIN 4 10,000 MW (March 19, 1996)
  • K943966 — VIVAPORE 2 (April 11, 1995)
  • K943965 — VIVAPORE 10 (April 11, 1995)
  • K941326 — ULTRAFREE-CL (May 27, 1994)
  • K935496 — NANOSEP N10 (April 26, 1994)
  • K930168 — CENTRICON -50 CONCENTRATOR (August 5, 1993)
  • K893733 — CENTRICON CONCENTRATOR (July 20, 1989)
  • K871290 — CENTRICELL(TM) (August 5, 1987)
  • K870690 — CENTRIPREP CONCENTRATOR (March 19, 1987)

FDA data resources