Product code ICL
- Device name
- Carbol Fuchsin
- Medical specialty
- Hematology
- Device class
- 1
- Regulation number
- 864.1850
- Review panel
- PA
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- Y
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K890148 | ATS TB RAPID STAIN SET PRODUCT #034-45 | Alpha-Tec Systems, Inc. | 1989-01-24 |
| K842933 | CARBOL-FUCHSIN, ZIEHL-NEEDSEN | E K Ind., Inc. | 1984-09-11 |
| K792483 | STAINS, COUNTERSTAINS & GEN. PURPOSE | Laboratory Products, Inc. | 1979-12-18 |
| K771390 | HISTOCHEMICAL AFB DEMONSTRATION | Harleco | 1977-08-22 |
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|---|---|---|---|
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| 00848838065767 | REMEL | REMEL, INC. | 2022-12-23 |
| 00848838065958 | REMEL | REMEL, INC. | 2022-12-23 |
| 00816085022086 | Alpha-Tec Systems | Alpha-TEC Systems, Inc. | 2022-08-10 |
| 00816085023595 | Alpha-Tec Systems | Alpha-TEC Systems, Inc. | 2022-08-08 |
| 00816085023588 | Alpha-Tec Systems | Alpha-TEC Systems, Inc. | 2022-08-08 |
| 00816085023441 | Alpha-Tec Systems | Alpha-TEC Systems, Inc. | 2022-08-08 |
| 00816085020853 | Alpha-Tec Systems | Alpha-TEC Systems, Inc. | 2022-08-08 |
| 00816085020822 | Alpha-Tec Systems | Alpha-TEC Systems, Inc. | 2022-08-08 |
| 00816085023458 | Alpha-Tec Systems | Alpha-TEC Systems, Inc. | 2022-08-08 |
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| SO359852042008 | Rowley Biochemical Kinyoun's Carbol Fuchsin Solution | TRANSENE COMPANY, INC. | 2019-09-16 |
| SO471852042008 | Rowley Biochemical Ziehl-Neelsen Carbol Fuchsin Solution | TRANSENE COMPANY, INC. | 2019-09-16 |
| SO490852042008 | Rowley Biochemical Carbol Fuchsin | TRANSENE COMPANY, INC. | 2019-09-16 |
| 30382902125113 | BD BBL™ TB Carbolfuchsin ZN | BECTON, DICKINSON AND COMPANY | 2018-05-25 |
| 30382902125182 | BD BBL™ TB Carbolfuchsin KF | BECTON, DICKINSON AND COMPANY | 2018-05-25 |