FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
LSA 290 ASSAY REAGENTS/NEPHELOMETRIC
K Number: K801909
·
Decision Sep 26, 1980
Classifications
1
FEI Numbers
1
Registration Numbers
1
Same Product Code
4
Applicant Total
54
Review Days
46
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Basic Information
- Device Name
- LSA 290 ASSAY REAGENTS/NEPHELOMETRIC
- K Number
- K801909
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 866.5420
- Medical Specialty
- Immunology
- Decision
- Substantially Equivalent
- Applicant
- J.T. Baker Chemical Co.
- Date Received
- August 11, 1980
- Decision Date
- September 26, 1980
- Product Code
- DEX
- 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 |
|---|---|---|---|
| DEX | Alpha-1-B-Glycoprotein, Antigen, Antiserum, Control | FDA class 1 | Immunology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (DEX), ordered by most recent decision date.
ANTI SERA TO HUMAN OROSCOMUCOID
FDA 510(k)
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HUMAN ALPHA, ACID GLYCOPROTEIN
FDA 510(k)
FDA Class 1
·Immunology
ALPHA-1-ACID GLYCOPROTEIN SERUM, ANTI-HU
FDA 510(k)
FDA Class 1
·Immunology
SERUM, ALPHA-1-GLYCOPROTEIN ANTI-HUMAN
FDA 510(k)
FDA Class 1
·Immunology
Other Clearances by J.T. Baker Chemical Co.
| K Number | Device Name | ||
|---|---|---|---|
| K803128 | SERIES 810 PLATELET ANALYZER | Apr 3, 1981 | Substantially Equivalent |
| K802080 | BAKER DIAG. ULTRARATE CHLORIDE KIT | Oct 10, 1980 | Substantially Equivalent |
| K802035 | BAKER DIAG. ULTRARATE CO2 REAGENT KIT | Sep 26, 1980 | Substantially Equivalent |
| K801662 | J.T. BAKER ALPHA-2-MACROGLOBULIN NEPH. | Sep 16, 1980 | Substantially Equivalent |
| K801669 | J.T. BAKER ALPHA-1-ANTITRYPSIN NEPHELO | Sep 16, 1980 | Substantially Equivalent |
| K801661 | J.T. BAKER CERULOPLASMIN NEPHELOMETRIC | Sep 16, 1980 | Substantially Equivalent |
| K801795 | BAKER DIAGNOSTIC ULTRA-RATE SODIUM/POT. | Sep 16, 1980 | Substantially Equivalent |
| K801362 | ALBUMIN NEPHELOMETRIC ASSAY | Jul 21, 1980 | Substantially Equivalent |
| K801432 | HEMOPEXIN NEPHELOMETRIC ASSAY | Jul 8, 1980 | Substantially Equivalent |
| K801434 | J.T. BAKER TRANSFERRIN NEPHELOMETRIC ASS | Jul 8, 1980 | Substantially Equivalent |