Saitron 430 Random Access Chemistry Analyzer
FDA 510(k) K884035 · Sclavo, Inc.
510(k) numberK884035
Submission
- Device name
- Saitron 430 Random Access Chemistry Analyzer
- Applicant
- Sclavo, Inc.
Wayne, NJ, US - Received
- September 23, 1988
- Decision date
- December 29, 1988
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- JJE – Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 862.2160
- Specialty
- Clinical Chemistry
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| K873496 | Atypical CholinesteraseDIH · Traditional | 01/27/1989SE |
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Questions and answers
When was Saitron 430 Random Access Chemistry Analyzer cleared by the FDA?
Saitron 430 Random Access Chemistry Analyzer (K884035) received a 510(k) decision of Substantially Equivalent on December 29, 1988, 97 days after the submission was received.
What is the product code of K884035?
The FDA product code is JJE – Analyzer, Chemistry (Photometric, Discrete), For Clinical Use, a Class I (low risk) device regulated under 21 CFR 862.2160.