RIA KIT FOR TRYPSIN
FDA 510(k) clearance K791202 · decided 1979-11-05
Clearance details
- K-number
- K791202
- Device name
- RIA KIT FOR TRYPSIN
- Applicant
- Cis Radiopharmaceuticals, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1979-06-28
- Decision date
- 1979-11-05
- Days to decision
- 130 days
- Clearance type
- Traditional
- Product code
- JNO
- Device class
- 1
- Regulation number
- 862.1725
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Mchenry, IL, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Cis Radiopharmaceuticals
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 |
|---|---|---|
| AUTODELFIA NEONATAL IRT KIT (K110274) | Wallac Oy, A Subsidiary of Perkinelmer, Inc. | 2011-06-10 |
| GSP NEONATAL IRT KIT (3306-001U) (K102419) | Wallac Oy, Subsidiary of Perkinelmer | 2010-12-16 |
| 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 |
| TRYPIN (125I) RIA KIT (K811805) | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1981-08-31 |
Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| DiaSorin TRYPSIK Kits, Catalog Number P2573-(assay used as a procedure for the quantitativ recall (Z-0748-2007) | Diasorin Inc. | 2007-04-14 |