J.T. Baker ALPHA-2-MACROGLOBULIN Neph.
FDA 510(k) K801662 · J.T. Baker Chemical Co.
510(k) numberK801662
Submission
- Device name
- J.T. Baker ALPHA-2-MACROGLOBULIN Neph.
- Applicant
- J.T. Baker Chemical Co.
Mchenry, IL, US - Received
- July 21, 1980
- Decision date
- September 16, 1980
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- DEP – Lambda, Peroxidase, Antigen, Antiserum, Control
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.5550
- Specialty
- Immunology
More from J.T. Baker Chemical Co.
| 510(k) | Device | Decision |
|---|---|---|
| K803128 | Series 810 Platelet AnalyzerGKL · Traditional | 04/03/1981SE |
| K802080 | Baker Diag. Ultrarate Chloride KitJFS · Traditional | 10/10/1980SE |
| K802035 | Baker Diag. Ultrarate CO2 Reagent KitJFL · Traditional | 09/26/1980SE |
| K801909 | Lsa 290 Assay Reagents/NephelometricDEX · Traditional | 09/26/1980SE |
| K801795 | Baker Diagnostic Ultra-Rate Sodium/Pot.JGS · Traditional | 09/16/1980SE |
| K801669 | J.T. Baker ALPHA-1-ANTITRYPSIN NepheloDEM · Traditional | 09/16/1980SE |
| K801661 | J.T. Baker Ceruloplasmin NephelometricDDB · Traditional | 09/16/1980SE |
| K801362 | Albumin Nephelometric AssayJQX · Traditional | 07/21/1980SE |
| K801434 | J.T. Baker Transferrin Nephelometric AssDDG · Traditional | 07/08/1980SE |
| K801433 | Haptoglobin Nephelometric AssayDAD · Traditional | 07/08/1980SE |
Questions and answers
When was J.T. Baker ALPHA-2-MACROGLOBULIN Neph. cleared by the FDA?
J.T. Baker ALPHA-2-MACROGLOBULIN Neph. (K801662) received a 510(k) decision of Substantially Equivalent on September 16, 1980, 57 days after the submission was received.
What is the product code of K801662?
The FDA product code is DEP – Lambda, Peroxidase, Antigen, Antiserum, Control, a Class II (moderate risk) device regulated under 21 CFR 866.5550.