TDX THEOPHYLLINE
FDA 510(k) clearance K833070 · decided 1983-11-14
Clearance details
- K-number
- K833070
- Device name
- TDX THEOPHYLLINE
- Applicant
- Abbott Laboratories
- Decision
- Substantially Equivalent
- Date received
- 1983-09-08
- Decision date
- 1983-11-14
- Days to decision
- 67 days
- Clearance type
- Traditional
- Product code
- LER
- Device class
- 2
- Regulation number
- 862.3880
- Medical specialty
- Clinical Toxicology
- Advisory committee
- Clinical Toxicology
- Location
- Abbott Park, IL, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Abbott Laboratories
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| THEOPHYLLINE FPIA REAGENT SET AND CALIBRATORS (K942192) | Sigma Diagnostics, Inc. | 1994-07-13 |
| CEDIA(R) THEOPHYLLINE ASSAY/MODIFICATION (K905521) | Microgenics Corp. | 1990-12-26 |
| TURBOX THEOPHYLLINE ASSAY (K882570) | Unipath , Ltd. | 1988-11-10 |
| IMMPULSE COATED TUBE THEOPHYLLINE ASSAY REAGENTS (K864409) | Sclavo, Inc. | 1986-12-22 |
| THEOFAST(TM) TEST PACKAGE (K863475) | 3M Company | 1986-11-05 |
| THEOPHYLLINE KIT FLUORESCENCE POLARIZA- (K842585) | Windsor Laboratories, Inc. | 1984-09-26 |
| IMMPULSE THEOPHYLLINE ASSAY REAGENTS (K840758) | Paragon Diagnostics, Inc. | 1984-04-04 |
| AMWA TDA THEOPHYLLINE TEST (K831514) | Miles Laboratories, Inc. | 1983-06-30 |
| COBAS STANDARD FOR TOTAL PROTEIN (K823576) | Hoffmann-La Roche, Inc. | 1983-01-07 |
| AMERIFLUOR THEOPHYLLINE FLUORESCENT IMM (K820397) | American Diagnostic Corp. | 1982-03-02 |
| EMIT-AAD THEOPHYLLINE ASSAY (K813240) | Syva Co. | 1981-12-03 |
| AMES TDA THEOPHYLLINE TEST (K812518) | Miles Laboratories, Inc. | 1981-09-23 |
Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| IMx Theophylline Reagent Pack (List 1A81-20) In Vitro test. This reagent system is compose recall (Z-0958-2007) | Abbott Diagnostic International, Ltd. | 2007-07-03 |
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 |