Carbol-Fuchsin, Ziehl-Needsen
FDA 510(k) K842933 · E K Ind., Inc.
510(k) numberK842933
Submission
- Device name
- Carbol-Fuchsin, Ziehl-Needsen
- Applicant
- E K Ind., Inc.
Mchenry, IL, US - Received
- July 25, 1984
- Decision date
- September 11, 1984
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- ICL – Carbol Fuchsin
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 864.1850
- Specialty
- Hematology
Other 510(k)s with product code ICL
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K890148 | Ats TB Rapid Stain Set Product #034-45ICL · Traditional | Alpha-Tec Systems, Inc. | 01/24/1989SE |
| K792483 | Stains, Counterstains & Gen. PurposeICL · Traditional | Laboratory Products, Inc. | 12/18/1979SE |
| K771390 | Histochemical Afb DemonstrationICL · Traditional | Harleco | 08/22/1977SE |
More from Harleco
| 510(k) | Device | Decision |
|---|---|---|
| K842931 | Drabkin ReagentKAG · Traditional | 09/21/1984SE |
| K842938 | Acetic Acid 1% V/VGGK · Traditional | 09/14/1984SE |
| K842937 | Acetic Acid 2% V/VGGK · Traditional | 09/12/1984SE |
| K842936 | Acetic Acid, 3% V/VGGK · Traditional | 09/12/1984SE |
| K842935 | Acetic Acid, 5% V/VGGK · Traditional | 09/12/1984SE |
| K842934 | Decolorizing Fluic, Acid-Alcohol 3%PPM · Traditional | 09/12/1984SE |
| K842930 | Gomori's Trichrome StainLED · Traditional | 09/11/1984SE |
| K842928 | Jenner Blood StainKJX · Traditional | 09/11/1984SE |
| K842927 | Light Green SF 1%HYS · Traditional | 09/11/1984SE |
| K842926 | Methylene Blue Stain, LoefflerKFC · Traditional | 09/11/1984SE |
Questions and answers
When was Carbol-Fuchsin, Ziehl-Needsen cleared by the FDA?
Carbol-Fuchsin, Ziehl-Needsen (K842933) received a 510(k) decision of Substantially Equivalent on September 11, 1984, 48 days after the submission was received.
What is the product code of K842933?
The FDA product code is ICL – Carbol Fuchsin, a Class I (low risk) device regulated under 21 CFR 864.1850.