TRYPIN (125I) RIA KIT
FDA 510(k) clearance K811805 · decided 1981-08-31
Clearance details
- K-number
- K811805
- Device name
- TRYPIN (125I) RIA KIT
- Applicant
- Bd Becton Dickinson Vacutainer Systems Preanalytic
- Decision
- Substantially Equivalent
- Date received
- 1981-06-24
- Decision date
- 1981-08-31
- Days to decision
- 68 days
- Clearance type
- Traditional
- Product code
- JNO
- Device class
- 1
- Regulation number
- 862.1725
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Washington, DC, US
- Third-party review
- No
- Expedited review
- No
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| NUCLITRYP(TM)(I125)-HUMAN PANCREA CATH TRY RAD KIT (K932406) | Nuclear Diagnostics, Inc. | 1993-12-02 |
| MRI NEO-TRYP TRYPSIN RIA (K883011) | Microbiological Research Corp. | 1989-04-26 |
| TRYPSIN RIA KIT (K861097) | Microanalytic Research, Inc. | 1986-05-29 |
| RIA KIT FOR TRYPSIN (K791202) | Cis Radiopharmaceuticals, Inc. | 1979-11-05 |
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| OXYCELL (N5798/S007) | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1995-07-24 |
| OXYCEL OXIDIZED (N5798/S005) | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1991-02-08 |
| OXYCELL (N5798/S006) | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1991-02-08 |
| MINI BALLOON (P780011/S012) | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1989-10-30 |
| MINI BALLOON (P780011/S011) | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1988-10-18 |
| MINI BALLOON (P780011/S010) | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1988-01-29 |
| MINI BALLOON (P780011/S007) | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1985-01-23 |
| BBL SCEPTOR SYSTEM MICRODILUTION ANTIMICROBIC SUSC (P800030/S006) | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1984-11-05 |