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Indirect Enzyme Linked Immunosorbent Assay Igg Ant

by Biotech Research Laboratories, Inc. 510(k)

Active United States

510(k) K853484

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK853484 Date5 Feb 1986ClearedStatusActive

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Recalls

0 recalls · FDA

No FDA recalls on record, checked 11 Oct 2026.

Specification

510(k)

510(k) Number
FDA Product Code
GNP
Device Class
Class I
Regulation
21 CFR Part 866.3235
Advisory Committee
Microbiology
FDA Decision
SESE Substantially Equivalent

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