FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
IRMA-COUNT TSH RKTS1, RKTS2, RKTS5, RKTSX
K Number: K872305
·
Decision Jul 1, 1987
Classifications
1
FEI Numbers
75
Registration Numbers
75
Same Product Code
240
Applicant Total
321
Review Days
23
Basic Information
- Device Name
- IRMA-COUNT TSH RKTS1, RKTS2, RKTS5, RKTSX
- K Number
- K872305
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.1690
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Applicant
- DIAGNOSTIC PRODUCTS CORP.
- Date Received
- June 8, 1987
- Decision Date
- July 1, 1987
- 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.
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
Elecsys TSH
FDA 510(k)
FDA Class 2
·Clinical Chemistry
Other Clearances by DIAGNOSTIC PRODUCTS CORP.
| K Number | Device Name | ||
|---|---|---|---|
| K063045 | IMMULITE 2000, IMMULITE 2500 VANCOMYCIN | Dec 5, 2006 | Substantially Equivalent |
| K034055 | IMMULITE 2500 CK-MB, 2500 MYOGLOBIN, 2500 STAT TROPONIN I | Jan 21, 2004 | Substantially Equivalent |
| K033234 | IMMULITE 2500 AUTOMATED IMMUNOASSAY ANALYZER | Dec 12, 2003 | Substantially Equivalent |
| K032881 | IMMULITE/IMMULITE 1000 TOTAL TESTOSTERONE AND IMMULITE 2000 TOTAL TESTOSTERONE | Oct 10, 2003 | Substantially Equivalent |
| K023152 | IMMULITE 2000 ALLERGEN-SPECIFIC IGE | Dec 17, 2002 | Substantially Equivalent |
| K023304 | IMMULITE/IMMULITE 1000 CALCITONIN, MODEL LKCL AND IMMULITE 2000 CALCITONIN, MODEL L2KCL | Dec 9, 2002 | Substantially Equivalent |
| K022603 | IMMULITE 1000 AUTOMATED IMMUNOASSAY ANALYZER | Aug 21, 2002 | Substantially Equivalent |
| K022118 | IMMULITE TURBO CK-MB, MODELS LSKCP1 (100 TESTS), LSKCP5 (500 TESTS) | Jul 22, 2002 | Substantially Equivalent |
| K021257 | ANA LINE BLOT, CATALOG NUMBER: KALABI (20 TESTS) | Jun 3, 2002 | Substantially Equivalent |
| K021206 | IMMULITE 2000 SPECIFIC ALLERGENS | May 30, 2002 | Substantially Equivalent |