Stat Ultra Violet Liquid
FDA 510(k) K781432 · Beckman Instruments, Inc.
510(k) numberK781432
Submission
- Device name
- Stat Ultra Violet Liquid
- Applicant
- Beckman Instruments, Inc.
Mchenry, IL, US - Received
- August 21, 1978
- Decision date
- October 3, 1978
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- JHS – Differential Rate Kinetic Method, Cpk Or Isoenzymes
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.1215
- Specialty
- Clinical Chemistry
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| K952250 | Stratus Ck-Mb Dendrimer Fluorometric Enzyme Immunoassay & Stratus Ck-Mb Dendrimer High…JHS · Traditional | Dade Intl., Inc. | 07/17/1995SE |
| K945083 | Access Ck-Mb ReagentsJHS · Traditional | Bio-Rad Laboratories, Inc. | 11/21/1994SE |
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Questions and answers
When was Stat Ultra Violet Liquid cleared by the FDA?
Stat Ultra Violet Liquid (K781432) received a 510(k) decision of Substantially Equivalent on October 3, 1978, 43 days after the submission was received.
What is the product code of K781432?
The FDA product code is JHS – Differential Rate Kinetic Method, Cpk Or Isoenzymes, a Class II (moderate risk) device regulated under 21 CFR 862.1215.