PAP-TRAY I (CATALOG #C600-1)
FDA 510(k) clearance K761000 · decided 1976-12-06
Clearance details
- K-number
- K761000
- Device name
- PAP-TRAY I (CATALOG #C600-1)
- Applicant
- Lerner Laboratories, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1976-11-08
- Decision date
- 1976-12-06
- Days to decision
- 28 days
- Clearance type
- Traditional
- Product code
- LEA
- Device class
- 1
- Regulation number
- 864.4010
- Medical specialty
- Pathology
- Advisory committee
- Pathology
- 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 |
|---|---|---|
| TIF FECAL TEST (K873594) | Devetec, Inc. | 1987-09-29 |
| CYTOLOGY FIXATIVE (K770592) | Surgipath Medical Industries, Inc. | 1977-05-20 |
| PAP-TRAY II (CATALOG #C600-2) (K761001) | Lerner Laboratories, Inc. | 1976-12-06 |
Recalls involving this device
No recalls on record reference this clearance.