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510(k) K781070

SECOND ANTIBODY by Pcl-Ria, Inc. — Product Code KTS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 10, 1978
Date Received
June 26, 1978
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Second Antibody (Species Specific Anti-Animal Gamma Globulin)
Device Class
Class II
Regulation Number
866.5510
Review Panel
IM
Submission Type

Other clearances by Pcl-Ria, Inc.

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  • K822935 — THYROID STIMULATING HORMONE (November 1, 1982)
  • K822612 — T3 UPTAKE KITS (September 30, 1982)
  • K820886 — THYROXINE T4 KIT (April 16, 1982)
  • K820358 — FOLLICLE STIMULATING HORMONE KIT (March 26, 1982)
  • K820357 — LUTEINIZING HORMONE KIT (March 25, 1982)
  • K812666 — THYROXINE (T4) 125I (October 2, 1981)
  • K810867 — FOLLICLE STIMULATING HORMONE (FSH) (April 14, 1981)
  • K810852 — FOLLICLE STIMULATING HORMONE ANTISERUM (April 8, 1981)

Other clearances for product code KTS

  • K813508 — SAC-CEL (December 29, 1981)
  • K792637 — CENTRIA-SET TYPE D(ANTI-SHEEP/GOAT) (January 11, 1980)
  • K792636 — CENTRIA RADIOIMMUNOASSAY SEPARATION (January 11, 1980)