FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
AIA-PACK TSH 3RD-GEN ASSAY
K Number: K972586
·
Decision Aug 29, 1997
Classifications
1
FEI Numbers
73
Registration Numbers
73
Same Product Code
241
Applicant Total
41
Review Days
49
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Basic Information
- Device Name
- AIA-PACK TSH 3RD-GEN ASSAY
- K Number
- K972586
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.1690
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Tosoh Medics, Inc.
- Date Received
- July 11, 1997
- Decision Date
- August 29, 1997
- 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 |
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Other Clearances by Tosoh Medics, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K023893 | ST AIA-PACK CEA ENZYME IMMUNOASSAY | Dec 18, 2002 | Substantially Equivalent |
| K023894 | ST AIA-PACK AFP ENZYME IMMUNOASSAY | Dec 17, 2002 | Substantially Equivalent |
| K023091 | ST AIA-PACK TESTOSTERONE ASSAY | Dec 17, 2002 | Substantially Equivalent |
| K023891 | ST AIA-PACK CA 125 ENZYME IMMUNOASSAY | Dec 6, 2002 | Substantially Equivalent |
| K020489 | G7 AUTOMATED HPLC ANALYZER, BETA-THALASSEMIA MODE | May 14, 2002 | Substantially Equivalent |
| K012820 | AIA-PACK CTNI 2ND-GEN ASSAY | Dec 14, 2001 | Substantially Equivalent |
| K011434 | G7 AUTOMATED HPLC ANALYZER | Sep 18, 2001 | Substantially Equivalent |
| K010796 | AIA-PACK BRCA, ST AIA PACK BRCA | Aug 16, 2001 | Substantially Equivalent |
| K992365 | AIA-PACK FOLATE ASSAY | Aug 10, 1999 | Substantially Equivalent |
| K990431 | AIA-PACK CA 125 | Jun 3, 1999 | Substantially Equivalent |