Albumin Nephelometric Assay
FDA 510(k) K801362 · J.T. Baker Chemical Co.
510(k) numberK801362
Submission
- Device name
- Albumin Nephelometric Assay
- Applicant
- J.T. Baker Chemical Co.
Mchenry, IL, US - Received
- June 9, 1980
- Decision date
- July 21, 1980
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- JQX – Nephelometer, For Clinical Use
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 862.2700
- Specialty
- Clinical Chemistry
Other 510(k)s with product code JQX
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K962294 | Immage Immunochemistry SystemJQX · Traditional | Beckman Instruments, Inc. | 08/21/1996SE |
| K922273 | Array(R) 360JQX · Traditional | Beckman Instruments, Inc. | 08/19/1992SE |
| K885263 | Qms(Tm) - TheophyllineJQX · Traditional | Seradyn, Inc. | 03/28/1989SE |
| K851253 | TDX Analyzer W/Nephelometry CarouselJQX · Traditional | Abbott Laboratories | 04/30/1985SE |
| K851234 | A-Just Turbidity MeterJQX · Traditional | Abbott Laboratories | 04/29/1985SE |
| K801089 | J.T. Baker NephelometerJQX · Traditional | J.T. Baker Chemical Co. | 05/28/1980SE |
| K792045 | Biovation NephelometerJQX · Traditional | Biovation, Inc. | 10/30/1979SE |
| K790103 | Nephelometer, MIC-2000 LaserJQX · Traditional | Dynatech Corp. | 03/12/1979SE |
| K781554 | RAD-291JQX · Traditional | Organon, Inc. | 10/11/1978SE |
| K781644 | Antibiotic NephelometerJQX · Traditional | Biovation, Inc. | 10/03/1978SE |
More from Biovation, 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 |
| 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 |
| K801662 | J.T. Baker ALPHA-2-MACROGLOBULIN Neph.DEP · Traditional | 09/16/1980SE |
| K801661 | J.T. Baker Ceruloplasmin NephelometricDDB · Traditional | 09/16/1980SE |
| K801434 | J.T. Baker Transferrin Nephelometric AssDDG · Traditional | 07/08/1980SE |
| K801433 | Haptoglobin Nephelometric AssayDAD · Traditional | 07/08/1980SE |
Questions and answers
When was Albumin Nephelometric Assay cleared by the FDA?
Albumin Nephelometric Assay (K801362) received a 510(k) decision of Substantially Equivalent on July 21, 1980, 42 days after the submission was received.
What is the product code of K801362?
The FDA product code is JQX – Nephelometer, For Clinical Use, a Class I (low risk) device regulated under 21 CFR 862.2700.