TIPSEP-TBG ASSAY— 510(k) K861735

Substantially Equivalent

Nuclear Diagnostics, Inc.

FDA 510(k) clearance K861735 for TIPSEP-TBG ASSAY, Substantially Equivalent on 1986-06-13. Applicant: Nuclear Diagnostics, Inc.. Device class: 2.

Clearance details

Applicant: Nuclear Diagnostics, Inc.
Product code: Code CEE
Device class: Class 2
Regulation: 21 CFR 862.1685
Advisory panel: Clinical Chemistry
Date received: 1986-05-06
Decision date: 1986-06-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Troy, MI, US

Download summary PDF View on FDA.gov ↗

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 Nuclear Diagnostics, Inc.

K923917 — ELIPASE HUMAN PANCREATIC LIPASE ENZYMEIMMUNOASSAY1994-02-25
K932406 — NUCLITRYP(TM)(I125)-HUMAN PANCREA CATH TRY RAD KIT1993-12-02
K872177 — TIPSEP-CORTISOL RIA DIAGNOSTIC KIT1987-06-17
K862312 — ENZLIPASE, ENZYMATIC LIPASE KIT1986-09-26
K860472 — NUCLEAR LASER ALIGNMENT SYSTEM FOR CARDIC STRESS1986-07-03

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