Human Plasma Control for Cea-Roche
FDA 510(k) K822219 · Hoffmann-La Roche, Inc.
510(k) numberK822219
Submission
- Device name
- Human Plasma Control for Cea-Roche
- Applicant
- Hoffmann-La Roche, Inc.
Walker, MI, US - Received
- July 26, 1982
- Decision date
- December 28, 1982
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- JJX – Single (Specified) Analyte Controls (Assayed And Unassayed)
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 862.1660
- Specialty
- Clinical Chemistry
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| K830461 | Abuscreen Radioummunoassay-MethaqualoneKXS · Traditional | 03/24/1983SE |
| K830460 | Abuscreen Radioimmunoassay for MorphineDOE · Traditional | 03/24/1983SE |
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Questions and answers
When was Human Plasma Control for Cea-Roche cleared by the FDA?
Human Plasma Control for Cea-Roche (K822219) received a 510(k) decision of Substantially Equivalent on December 28, 1982, 155 days after the submission was received.
What is the product code of K822219?
The FDA product code is JJX – Single (Specified) Analyte Controls (Assayed And Unassayed), a Class I (low risk) device regulated under 21 CFR 862.1660.