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510(k) K913671

HUMAN IGD IMMUNOLOGICAL NL TEST KIT by The Binding Site, Ltd. — Product Code CZJ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 2, 1991
Date Received
August 19, 1991
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Igd, Antigen, Antiserum, Control
Device Class
Class II
Regulation Number
866.5510
Review Panel
IM
Submission Type

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Other clearances for product code CZJ

  • K092450 — HUMAN IGD KIT FOR USE ON SPAPLUS (December 28, 2009)
  • K051299 — IGD DIAGNOSTIC TEST KITS (November 23, 2005)
  • K002561 — SHEEP ANTI-HUMAN IGD IMMUNOFIXATION GRADE KIT (October 26, 2000)
  • K883001 — QM300 CALIBRATOR D PACK (September 22, 1988)
  • K872834 — TITAN GEL IFE ANTISERUM TO IGD-9409 & IGE-9410 (August 12, 1987)
  • K831956 — DETERM. SIZE 72 RADIAL-HUMAN IGD (July 18, 1983)
  • K772327 — LAS-R HUMAN IGD TEST (February 28, 1978)