FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
AIA-PACK T-U
K Number: K913663
·
Decision Sep 30, 1991
Classifications
1
FEI Numbers
33
Registration Numbers
33
Same Product Code
92
Applicant Total
11
Review Days
45
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Basic Information
- Device Name
- AIA-PACK T-U
- K Number
- K913663
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.1715
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Tosoh Corp.
- Date Received
- August 16, 1991
- Decision Date
- September 30, 1991
- Product Code
- KHQ
- 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 |
|---|---|---|---|
| KHQ | Radioassay, Triiodothyronine Uptake | FDA class 2 | Clinical Chemistry |
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Other Clearances by Tosoh Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K023240 | ST AIA-PACK CA 19-9 | Dec 23, 2002 | Substantially Equivalent |
| K023239 | AIA-PACK CA 19-9 | Dec 23, 2002 | Substantially Equivalent |
| K923021 | AIA-1200DX - AUTOMATED ENZYME IMMUNOASSAY SYSTEM | Jul 21, 1992 | Substantially Equivalent |
| K913298 | AIA-PACK CK-MB | Sep 27, 1991 | Substantially Equivalent |
| K913493 | AIA-PACK FT4 | Sep 10, 1991 | Substantially Equivalent |
| K903628 | AIA-PACK IRI | Sep 7, 1990 | Substantially Equivalent |
| K901965 | MPR-4A - MICRO-PLATE READER | May 10, 1990 | Substantially Equivalent |
| K901674 | AIA-600 AUTOMATED ENZYME IMMUNOASSAY SYSTEM | May 2, 1990 | Substantially Equivalent |
| K897001 | TOSOH AIA-PACK T3 | Mar 9, 1990 | Substantially Equivalent |
| K896982 | AIA-PACK T4 | Mar 9, 1990 | Substantially Equivalent |