Spectrophotometer Analysis Sys., AA-375
FDA 510(k) K770444 · Varian Assoc., Inc.
510(k) numberK770444
Submission
- Device name
- Spectrophotometer Analysis Sys., AA-375
- Applicant
- Varian Assoc., Inc.
Mchenry, IL, US - Received
- March 7, 1977
- Decision date
- April 8, 1977
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- JXR – Atomic Absorption Spectrophotometer, General Use
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 862.2850
- Specialty
- Clinical Chemistry
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|---|---|---|---|
| K900828 | Perkin-Elmer Aa 3100 Atomic Absorption Spectro.JXR · Traditional | The Perkin-Elmer Corp. | 04/09/1990SE |
| K875098 | Ciba Corning Model 644JXR · Traditional | Ciba Corning Diagnostics Corp. | 03/03/1988SE |
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| K842496 | ICP/6500 Inductively-Coupled Plasma-JXR · Traditional | The Perkin-Elmer Corp. | 08/10/1984SE |
| K830799 | Inductively-Coupled Plasma SpectrometerJXR · Traditional | The Perkin-Elmer Corp. | 04/12/1983SE |
| K820320 | Model 3030 Atomic Absorption Spectro-JXR · Traditional | The Perkin-Elmer Corp. | 03/01/1982SE |
| K810536 | ZEEMAN/5000 Graphite Furnace Atomic AbsbJXR · Traditional | The Perkin-Elmer Corp. | 03/17/1981SE |
| K792557 | Spectrophatometer Models 2280 & 2380AAJXR · Traditional | The Perkin-Elmer Corp. | 01/16/1980SE |
| K792146 | Atomic Spectroscopy SystemJXR · Traditional | The Perkin-Elmer Corp. | 11/30/1979SE |
| K791074 | Model MHS-20, Atomic Absorption AccessJXR · Traditional | The Perkin-Elmer Corp. | 08/22/1979SE |
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Questions and answers
When was Spectrophotometer Analysis Sys., AA-375 cleared by the FDA?
Spectrophotometer Analysis Sys., AA-375 (K770444) received a 510(k) decision of Substantially Equivalent on April 8, 1977, 32 days after the submission was received.
What is the product code of K770444?
The FDA product code is JXR – Atomic Absorption Spectrophotometer, General Use, a Class I (low risk) device regulated under 21 CFR 862.2850.