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510(k) K782143

RIA KIT, GLUCOSE by Serono Laboratories, Inc. — Product Code JME

K782143 is an FDA 510(k) premarket notification submitted by Serono Laboratories, Inc. for the device "RIA KIT, GLUCOSE". The FDA issued a decision of Substantially Equivalent on February 22, 1979. The device falls under product code JME (Radioimmunoassay, Glucagon), a Class I device regulated under 21 CFR 862.1335. Serono Laboratories, Inc. has at least 9 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 22, 1979
Date Received
December 27, 1978
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Radioimmunoassay, Glucagon
Device Class
Class I
Regulation Number
862.1335
Review Panel
CH
Submission Type

Other clearances by Serono Laboratories, Inc.

  • K834428 — ALDOSTERONE RADIOIMMUNOASSAY TEST KIT (March 2, 1984)
  • K810695 — ESTRIOL RADIOIMMUNOASSAY TEST KIT (March 31, 1981)
  • K810625 — HUMAN PLACENTAL LACTOGEN RADIOIMMUNO- (March 27, 1981)
  • K792043 — PAP-CHECK RIA KIT (October 30, 1979)
  • K790679 — ESTRADIOL RIA KIT (May 23, 1979)
  • K790440 — PROGESTERONE (May 3, 1979)
  • K782103 — RIA KIT, NEONATAL T4 (January 17, 1979)
  • K781733 — RIA KIT, PREG-STAT (December 20, 1978)
  • K781285 — INSULIN RIA KIT (August 14, 1978)

Other clearances for product code JME

  • K893975 — DOUBLE ANTIBODY GLUCAGON (October 31, 1989)
  • K771948 — GLUCAGON RIA MODULE (January 20, 1978)

FDA data resources