HISTOCHEMICAL AFB DEMONSTRATION
FDA 510(k) clearance K771390 · decided 1977-08-22
Clearance details
- K-number
- K771390
- Device name
- HISTOCHEMICAL AFB DEMONSTRATION
- Applicant
- Harleco
- Decision
- Substantially Equivalent
- Date received
- 1977-07-27
- Decision date
- 1977-08-22
- Days to decision
- 26 days
- Clearance type
- Traditional
- Product code
- ICL
- Device class
- 1
- Regulation number
- 864.1850
- Medical specialty
- Hematology
- Advisory committee
- Hematology
- Location
- Mchenry, IL, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| ATS TB RAPID STAIN SET PRODUCT #034-45 (K890148) | Alpha-Tec Systems, Inc. | 1989-01-24 |
| CARBOL-FUCHSIN, ZIEHL-NEEDSEN (K842933) | E K Ind., Inc. | 1984-09-11 |
| STAINS, COUNTERSTAINS & GEN. PURPOSE (K792483) | Laboratory Products, Inc. | 1979-12-18 |
Recalls involving this device
No recalls on record reference this clearance.