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510(k) K801943

BRAIN HEART INFUSION MICROBIOLOGICAL by Radiation Technology, Inc. — Product Code JSG

K801943 is an FDA 510(k) premarket notification submitted by Radiation Technology, Inc. for the device "BRAIN HEART INFUSION MICROBIOLOGICAL". The FDA issued a decision of Substantially Equivalent on September 9, 1980. The device falls under product code JSG (Culture Media, Non-Selective And Non-Differential), a Class I device regulated under 21 CFR 866.2300. Radiation Technology, Inc. has at least 6 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 9, 1980
Date Received
August 14, 1980
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Culture Media, Non-Selective And Non-Differential
Device Class
Class I
Regulation Number
866.2300
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)
  • 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)
  • K801847 — TRIPLE SUGAR IRON AGAR(MICRO/CULT/MEDIA (August 13, 1980)

Other clearances for product code JSG

  • K882495 — THIOGLYCOLLATE BROTH W/VITA. K & HEMIN - #T3007 (July 1, 1988)
  • K881542 — HEART INFUSION AGAR (April 18, 1988)
  • K881550 — OF BASAL MEDIUM (April 18, 1988)
  • K881563 — TRYPTOSE PHOSPHATE BROTH (April 18, 1988)
  • K881548 — MPH AGAR (April 18, 1988)
  • K881528 — CASEIN PEPTONE, LOW VITAMIN (April 18, 1988)
  • K881531 — BLOOD AGAR BASE, IMPROVED (April 18, 1988)
  • K881523 — DEXTROSE TRYPTONE BROTH (April 18, 1988)
  • K881558 — TRYPTOSE AGAR (April 18, 1988)
  • K881541 — GELATIN (April 18, 1988)

FDA data resources