FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
SANTEST 1AP
K Number: K862087
·
Decision Dec 3, 1986
Classifications
1
FEI Numbers
18
Registration Numbers
18
Same Product Code
10
Applicant Total
11
Review Days
184
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Basic Information
- Device Name
- SANTEST 1AP
- K Number
- K862087
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 866.5420
- Medical Specialty
- Immunology
- Decision
- Substantially Equivalent
- Applicant
- Scientific Sales Intl., Inc.
- Date Received
- June 2, 1986
- Decision Date
- December 3, 1986
- Product Code
- LKL
- Advisory Committee
- Immunology
- Review Advisory Committee
- IM
- 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 |
|---|---|---|---|
| LKL | Alpha-1-Acid-Glycoprotein, Antigen, Antiserum, Control | FDA class 1 | Immunology |
Similar 510(k) Clearances
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TECHNICON DPA-1 ANALYTE ALPHA 1 ACID GLYCOPROTEIN
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Other Clearances by Scientific Sales Intl., Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K953677 | LIGHTED FLEXGUIDE (MODIFICATION) | Aug 25, 1995 | Substantially Equivalent |
| K940799 | FLEXGUIDE | Aug 18, 1994 | Substantially Equivalent |
| K860996 | SANASSAY IC TEST | Mar 30, 1987 | Substantially Equivalent |
| K861336 | IAP PLATE TEST | Apr 25, 1986 | Substantially Equivalent |
| K853285 | MYWASHER 5 | Oct 4, 1985 | Substantially Equivalent |
| K853284 | MYREADER 7 | Oct 4, 1985 | Substantially Equivalent |
| K853380 | SPR 2 AUTODILUTER | Sep 12, 1985 | Substantially Equivalent |
| K853379 | PLATE INCUBATOR | Sep 3, 1985 | Substantially Equivalent |
| K833022 | AIR UTERINE DISPLACER-AUD 120 | Oct 14, 1983 | Substantially Equivalent |
| K802416 | SALEM/RESCE INTUBATION GUIDE | Oct 23, 1980 | Substantially Equivalent |