FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
SERUM THYROTROPIN ASSAY KIT, TIPSEP-
K Number: K833713
·
Decision Dec 29, 1983
Classifications
1
FEI Numbers
73
Registration Numbers
73
Same Product Code
241
Applicant Total
22
Review Days
69
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- SERUM THYROTROPIN ASSAY KIT, TIPSEP-
- K Number
- K833713
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.1690
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Applicant
- Nuclear Diagnostics, Inc.
- Date Received
- October 21, 1983
- Decision Date
- December 29, 1983
- Product Code
- JLW
- Advisory Committee
- Clinical Chemistry
- Review Advisory Committee
- CH
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| JLW | Radioimmunoassay, Thyroid-Stimulating Hormone | FDA class 2 | Clinical Chemistry |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (JLW), ordered by most recent decision date.
Atellica® IM TSH3-Ultra II (TSH3ULII)
FDA 510(k)
FDA Class 2
·Clinical Chemistry
Dimension LOCI Thyroid Stimulating Hormone Flex reagent cartridge (TSHL); Dimension LOCI Free Thyroxine Flex reagent cartridge (FT4L)
FDA 510(k)
FDA Class 2
·Clinical Chemistry
Maverick Diagnostic System TC1000; Maverick Test Panel A0.B0
FDA 510(k)
FDA Class 2
·Clinical Chemistry
ADVIA Centaur® TSH3-Ultra II (TSH3ULII)
FDA 510(k)
FDA Class 2
·Clinical Chemistry
Atellica® CI Analyzer, Atellica® IMThyroid Stimulating Hormone 3-Ultra (TSH3-UL), Atellica® CH Albumin BCP (AlbP)
FDA 510(k)
FDA Class 2
·Clinical Chemistry
Access TSH (3rd IS) Assay, DxI 9000 Access Immunoassay Analyzer
FDA 510(k)
FDA Class 2
·Clinical Chemistry
Other Clearances by Nuclear Diagnostics, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K923917 | ELIPASE HUMAN PANCREATIC LIPASE ENZYMEIMMUNOASSAY | Feb 25, 1994 | Substantially Equivalent |
| K932406 | NUCLITRYP(TM)(I125)-HUMAN PANCREA CATH TRY RAD KIT | Dec 2, 1993 | Substantially Equivalent |
| K872177 | TIPSEP-CORTISOL RIA DIAGNOSTIC KIT | Jun 17, 1987 | Substantially Equivalent |
| K862312 | ENZLIPASE, ENZYMATIC LIPASE KIT | Sep 26, 1986 | Substantially Equivalent |
| K860472 | NUCLEAR LASER ALIGNMENT SYSTEM FOR CARDIC STRESS | Jul 3, 1986 | Substantially Equivalent |
| K861735 | TIPSEP-TBG ASSAY | Jun 13, 1986 | Substantially Equivalent |
| K852291 | TIPSEP DIGOXIN RIA | Jun 25, 1985 | Substantially Equivalent |
| K823860 | NUCLIPASE (I125) PANCREATIC LIPASE | Apr 18, 1983 | Substantially Equivalent |
| K811558 | TSH-P.E.G. | Jun 18, 1981 | Substantially Equivalent |
| K810906 | TRI-LEVEL NDI CONTROL | Apr 14, 1981 | Substantially Equivalent |