FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
AIA-600 AUTOMATED ENZYME IMMUNOASSAY SYSTEM
K Number: K901674
·
Decision May 2, 1990
Classifications
1
FEI Numbers
51
Registration Numbers
51
Same Product Code
37
Applicant Total
11
Review Days
22
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Basic Information
- Device Name
- AIA-600 AUTOMATED ENZYME IMMUNOASSAY SYSTEM
- K Number
- K901674
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 862.2560
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Applicant
- Tosoh Corp.
- Date Received
- April 10, 1990
- Decision Date
- May 2, 1990
- Product Code
- KHO
- 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 |
|---|---|---|---|
| KHO | Fluorometer, For Clinical Use | FDA class 1 | 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 |
| K913663 | AIA-PACK T-U | Sep 30, 1991 | 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 |
| K897001 | TOSOH AIA-PACK T3 | Mar 9, 1990 | Substantially Equivalent |
| K896982 | AIA-PACK T4 | Mar 9, 1990 | Substantially Equivalent |