Amido Black 10B Stain
FDA 510(k) K792552 · Electrophoresis Corp. of America
510(k) numberK792552
Submission
- Device name
- Amido Black 10B Stain
- Applicant
- Electrophoresis Corp. of America
Mchenry, IL, US - Received
- December 10, 1979
- Decision date
- December 18, 1979
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- HZZ – Sudan Black B
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 864.1850
- Specialty
- Hematology
Other 510(k)s with product code HZZ
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K843684 | Sigma Sudan Black Reagent 380-1HZZ · Traditional | Sigma Chemical Co. | 10/31/1984SE |
More from Sigma Chemical Co.
| 510(k) | Device | Decision |
|---|---|---|
| K802396 | General Procedure Agarose FilmJJN · Traditional | 11/26/1980SE |
| K792553 | Agarose Barbital-Edta BufferJJN · Traditional | 01/29/1980SE |
| K792551 | Alkaline Phosphatase ReagentCJH · Traditional | 01/29/1980SE |
| K792548 | Alkaline Phosphatase MarkerCIN · Traditional | 01/29/1980SE |
| K792547 | Agarose Barbital BufferJJN · Traditional | 01/29/1980SE |
| K792574 | Mopso BufferJCC · Traditional | 01/21/1980SE |
| K792550 | Ponceau S Stain SetKQC · Traditional | 01/16/1980SE |
| K792549 | Fat Red 7B Stain SetHYD · Traditional | 12/18/1979SE |
| K791657 | LDH Isoenzyme ReagentCFE · Traditional | 09/17/1979SE |
| K791656 | Enzyme Stabilizing Reagent (Esr)CFE · Traditional | 09/17/1979SE |
Questions and answers
When was Amido Black 10B Stain cleared by the FDA?
Amido Black 10B Stain (K792552) received a 510(k) decision of Substantially Equivalent on December 18, 1979, 8 days after the submission was received.
What is the product code of K792552?
The FDA product code is HZZ – Sudan Black B, a Class I (low risk) device regulated under 21 CFR 864.1850.