NORMAL GOAT SERUM— 510(k) K833318

Substantially Equivalent

Biosan Laboratories, Inc.

FDA 510(k) clearance K833318 for NORMAL GOAT SERUM, Substantially Equivalent on 1984-01-03. Applicant: Biosan Laboratories, Inc.. Device class: 2.

Clearance details

Applicant: Biosan Laboratories, Inc.
Product code: Code DHX
Device class: Class 2
Regulation: 21 CFR 866.6010
Advisory panel: Immunology
Date received: 1983-09-26
Decision date: 1984-01-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Walker, MI, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code DHX

K223921 — Access CEA2023-09-22
K231517 — VITROS Immunodiagnostic Products CEA Reagent Pack2023-08-23
K200215 — ADVIA Centaur CEA Assay2020-04-13
K081615 — OLYMPUS CEA - CARCINOEMBRYONIC ANTIGEN2009-03-18
K080194 — VIDAS CEA (S) ASSAY2008-10-09

More clearances from Biosan Laboratories, Inc.

K860642 — PHOTRON VISUAL FIELD ANALYZER1986-04-15
K853812 — PHOTRON NEUROVISUAL STIMULATOR(MODIFICATION)1985-11-01
K832763 — TOBRAMYCIN REAGENT1984-03-23
K833193 — RADIOIMMUNOASSAY, THYROID STIMU. HORMONE1984-02-04
K834023 — BIO-SCIENCE LABORATORIES T4 REAGENT1984-01-24

Data sourced from openFDA. This site is unofficial and independent of the FDA.