Lsa 290 Assay Reagents/Nephelometric
FDA 510(k) K801909 · J.T. Baker Chemical Co.
510(k) numberK801909
Submission
- Device name
- Lsa 290 Assay Reagents/Nephelometric
- Applicant
- J.T. Baker Chemical Co.
Mchenry, IL, US - Received
- August 11, 1980
- Decision date
- September 26, 1980
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- DEX – Alpha-1-B-Glycoprotein, Antigen, Antiserum, Control
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 866.5420
- Specialty
- Immunology
Other 510(k)s with product code DEX
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K823765 | Anti Sera to Human OroscomucoidDEX · Traditional | Kent Laboratories, Inc. | 12/30/1982SE |
| K791341 | Human Alpha, Acid GlycoproteinDEX · Traditional | Beckman Instruments, Inc. | 08/16/1979SE |
| K781023 | ALPHA-1-ACID Glycoprotein Serum, Anti-HuDEX · Traditional | Icl Scientific | 08/14/1978SE |
| K760143 | Serum, ALPHA-1-GLYCOPROTEIN Anti-HumanDEX · Traditional | Oxford Laboratories, Inc. | 07/20/1976SE |
More from Oxford Laboratories, Inc.
| 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 |
| K801795 | Baker Diagnostic Ultra-Rate Sodium/Pot.JGS · Traditional | 09/16/1980SE |
| K801669 | J.T. Baker ALPHA-1-ANTITRYPSIN NepheloDEM · Traditional | 09/16/1980SE |
| K801662 | J.T. Baker ALPHA-2-MACROGLOBULIN Neph.DEP · 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 Lsa 290 Assay Reagents/Nephelometric cleared by the FDA?
Lsa 290 Assay Reagents/Nephelometric (K801909) received a 510(k) decision of Substantially Equivalent on September 26, 1980, 46 days after the submission was received.
What is the product code of K801909?
The FDA product code is DEX – Alpha-1-B-Glycoprotein, Antigen, Antiserum, Control, a Class I (low risk) device regulated under 21 CFR 866.5420.