TBG RIA— 510(k) K842167

Substantially Equivalent

Syncor Intl. Corp.

FDA 510(k) clearance K842167 for TBG RIA, Substantially Equivalent on 1984-07-09. Applicant: Syncor Intl. Corp.. Device class: 2.

Clearance details

Applicant: Syncor Intl. Corp.
Product code: Code CEE
Device class: Class 2
Regulation: 21 CFR 862.1685
Advisory panel: Clinical Chemistry
Date received: 1984-05-31
Decision date: 1984-07-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

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Recent devices under product code CEE

K952284 — AMERLITE TBG ASSAY1995-07-26
K930010 — ACCESS THYROID UPTAKE ASSAY1993-06-07
K910677 — IMMULITE(TM) T-UPTAKE1991-04-29
K905777 — MICROZYME THYROID UPTAKE ENZYME IMMUNOASSAY KIT1991-01-30
K900240 — DELFIA TBG KIT1990-03-30

More clearances from Syncor Intl. Corp.

K945825 — SECURE SAFETY INSERT1995-04-10
K851828 — IRRADIATOR FOR BIOLOGICAL MATERIALS IBL-437-C1985-09-19
K850433 — CESIUM 137 ENDOMETRIAL SOURCE1985-08-21
K852023 — CESIUM 137 SOURCE, CSM-4, CSM-11, CSM-411985-08-21
K852665 — SYNCOR TRICH DIRECT IMMUNOFLUORESCENCE ASSAY1985-08-13

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