Sigma Sudan Black Reagent 380-1
FDA 510(k) K843684 · Sigma Chemical Co.
510(k) numberK843684
Submission
- Device name
- Sigma Sudan Black Reagent 380-1
- Applicant
- Sigma Chemical Co.
St. Louis, MO, US - Received
- September 18, 1984
- Decision date
- October 31, 1984
- 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 |
|---|---|---|---|
| K792552 | Amido Black 10B StainHZZ · Traditional | Electrophoresis Corp. of America | 12/18/1979SE |
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| K933692 | Sigma CO2 Acid ReagentJFL · Traditional | 12/09/1993SE |
| K933695 | Sigma Electrolyte BufferJFL · Traditional | 10/22/1993SE |
| K933697 | Sigma Cre ReagentCGX · Traditional | 10/18/1993SE |
| K933693 | Sigma CX-3 Calibration Standard Level 2JIX · Traditional | 10/13/1993SE |
Questions and answers
When was Sigma Sudan Black Reagent 380-1 cleared by the FDA?
Sigma Sudan Black Reagent 380-1 (K843684) received a 510(k) decision of Substantially Equivalent on October 31, 1984, 43 days after the submission was received.
What is the product code of K843684?
The FDA product code is HZZ – Sudan Black B, a Class I (low risk) device regulated under 21 CFR 864.1850.