REVISED LABELING FOR TDX PHENCYCLIDINE
FDA 510(k) clearance K874484 · decided 1987-11-23
Clearance details
- K-number
- K874484
- Device name
- REVISED LABELING FOR TDX PHENCYCLIDINE
- Applicant
- Abbott Laboratories
- Decision
- Substantially Equivalent
- Date received
- 1987-10-30
- Decision date
- 1987-11-23
- Days to decision
- 24 days
- Clearance type
- Traditional
- Product code
- LCL
- Device class
- U
- Medical specialty
- Unknown
- Advisory committee
- Unknown
- Location
- Abbott Park, 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 |
|---|---|---|
| PSYCHEMEDICS RIA PHENCYCLIDINE ASSAY (K011275) | Psychemedics Corp. | 2002-02-11 |
| AT WORK DRUG TEST, MODEL 9145-25C; MODEL 9177-25C (K994093) | Phamatech | 1999-12-16 |
| PCP DIRECT RIA KIT (I-125) (K913864) | Immunalysis Corporation | 1991-10-11 |
| ABUSCREEN FP FOR PHENCYCLIDINE (K890882) | Roche Diagnostic Systems, Inc. | 1989-03-15 |
| EMIT HVA PHENCYCLIDINE ASSAY (K882179) | Syva Co. | 1988-07-12 |
| REVISED LABELING FOR ADX PHENCYCLIDINE (K880011) | Abbott Laboratories | 1988-02-11 |
| REVISED LABELING FOR SYVA PHENCYCLIDINE ASSAYS (K874626) | Syva Co. | 1988-01-11 |
| ABUSCREEN RADIOIMMUNOASSAY-PHENCYCLIDINE (K830481) | Hoffmann-La Roche, Inc. | 1983-03-24 |
| PHENCYCLIDINE DIRECT BLOOD RIA KIT (K800514) | Immunalysis Corporation | 1980-03-19 |
| ABUSCREEN RIA FOR PHENCYCLIDINE (K790655) | Hoffmann-La Roche, Inc. | 1979-06-15 |
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| ARCHITECT CORE / Alinity i Anti-HBc (P080023/S046) | Abbott Laboratories | 2025-04-03 |
| ARCHITECT AFP / Alinity i AFP (P120008/S030) | Abbott Laboratories | 2025-04-03 |
| ARCHITECT CORE-M / Alinity i Anti-HBc IgM (P060035/S043) | Abbott Laboratories | 2025-04-03 |
| ARCHITECT Total PSA / Alinity i Total PSA (P910007/S066) | Abbott Laboratories | 2025-04-03 |
| ARCHITECT Free PSA / Alinity i Free PSA (P980007/S055) | Abbott Laboratories | 2025-04-03 |
| ARCHITECT HBsAg Qualitative/Qualitative Confirmatory / Alinity i HBsAg Qualitative II/Qualitative II Confirmatory (P110029/S052) | Abbott Laboratories | 2025-04-03 |
| ARCHITECT HBsAg Next Qualitative / ARCHITECT HBsAg Next Confirmatory/ Alinity i HBsAg Next Qualitative/Alinity i HBsAg N (P210003/S013) | Abbott Laboratories | 2025-04-03 |
| ARCHITECT HBsAg Next Qualitative/Next Confirmatory, Alinity i HBsAg Next Qualitative/Next Confirmatory (P210003/S012) | Abbott Laboratories | 2024-09-30 |