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510(k) K760251

SET, ORAL ADMINISTRATION by Cis Radiopharmaceuticals, Inc. — Product Code LEY

K760251 is an FDA 510(k) premarket notification submitted by Cis Radiopharmaceuticals, Inc. for the device "SET, ORAL ADMINISTRATION". The FDA issued a decision of Substantially Equivalent on September 15, 1976. The device falls under product code LEY (Set, Oral Administration), a Class II device regulated under 21 CFR 876.5980. Cis Radiopharmaceuticals, Inc. has at least 8 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 15, 1976
Date Received
July 19, 1976
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Set, Oral Administration
Device Class
Class II
Regulation Number
876.5980
Review Panel
HO
Submission Type

Other clearances by Cis Radiopharmaceuticals, Inc.

  • K791860 — FERRITIN RIA KIT (December 6, 1979)
  • K792063 — FOLLICLE STIMULATING HORMONE (FSH) KIT (November 20, 1979)
  • K791202 — RIA KIT FOR TRYPSIN (November 5, 1979)
  • K792000 — LUTEINIZING HORMONE (LH) RIA (October 30, 1979)
  • K791051 — PROGESTERONE RADIOIMMUNOASSAY KIT (July 24, 1979)
  • K790003 — RIA KIT, PROLACTIN (March 12, 1979)
  • K780982 — KITS, RIA, MYOGLOBIN, HUMAN, MEASUREMENT (June 22, 1978)
  • K771878 — IRIDIUM 192 WIRES & PINS (October 27, 1977)

FDA data resources