510(k) K801909
- Device
- LSA 290 ASSAY REAGENTS/NEPHELOMETRIC
- Applicant
- J.T. BAKER CHEMICAL CO.
- 510(k) number
- K801909
- Product code
- DEX
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1980-09-26
- Date received
- 1980-08-11
- Regulation
- 866.5420
- Classification name
- Alpha-1-b-glycoprotein, Antigen, Antiserum, Control
- Medical specialty
- Immunology
- Review panel
- Immunology
- Device class
- 1
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Address
- 803 N. Front St. Suite 3 Mchenry IL US 60050 60050
FDA Registration Numbers#
- 3019906
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code DEX #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K823765 | ANTI SERA TO HUMAN OROSCOMUCOID | Kent Laboratories, Inc. | 1982-12-30 |
| K791341 | HUMAN ALPHA, ACID GLYCOPROTEIN | Beckman Instruments, Inc. | 1979-08-16 |
| K781023 | ALPHA-1-ACID GLYCOPROTEIN SERUM, ANTI-HU | Icl Scientific | 1978-08-14 |
| K760143 | SERUM, ALPHA-1-GLYCOPROTEIN ANTI-HUMAN | Oxford Laboratories, Inc. | 1976-07-20 |
Legacy Summary#
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FDA Review#
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