Array(R) 360
FDA 510(k) K922273 · Beckman Instruments, Inc.
510(k) numberK922273
Submission
- Device name
- Array(R) 360
- Applicant
- Beckman Instruments, Inc.
Brea, CA, US - Received
- May 14, 1992
- Decision date
- August 19, 1992
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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 |
| 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 |
| K801362 | Albumin Nephelometric AssayJQX · Traditional | J.T. Baker Chemical Co. | 07/21/1980SE |
| 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 |
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| K981354 | Access Afp Reagents on the Access Immunoassay Analyzer Model Number 33211LOJ · Traditional | 05/01/1998SE |
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| K974816 | Access(R) Psa Reagents on the Access(R) Immunoassay Analyzer 33220, 33225, 33229LTJ · Traditional | 02/20/1998SE |
| K974564 | Immage Immunochemistry System ALPHA-2-MACROGLOBULIN ReagentDEB · Traditional | 02/17/1998SE |
| K974110 | Immage Immunochemistry System Antithrombin III (AT3) ReagentJBQ · Traditional | 12/24/1997SE |
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Questions and answers
When was Array(R) 360 cleared by the FDA?
Array(R) 360 (K922273) received a 510(k) decision of Substantially Equivalent on August 19, 1992, 97 days after the submission was received.
What is the product code of K922273?
The FDA product code is JQX – Nephelometer, For Clinical Use, a Class I (low risk) device regulated under 21 CFR 862.2700.