MRI NEO-TRYP TRYPSIN RIA
FDA 510(k) clearance K883011 · decided 1989-04-26
Clearance details
- K-number
- K883011
- Device name
- MRI NEO-TRYP TRYPSIN RIA
- Applicant
- Microbiological Research Corp.
- Decision
- Substantially Equivalent
- Date received
- 1988-07-19
- Decision date
- 1989-04-26
- Days to decision
- 281 days
- Clearance type
- Traditional
- Product code
- JNO
- Device class
- 1
- Regulation number
- 862.1725
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Laguna Hills, CA, 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 |
|---|---|---|
| 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 |
| TRYPSIN RIA KIT (K861097) | Microanalytic Research, Inc. | 1986-05-29 |
| TRYPIN (125I) RIA KIT (K811805) | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1981-08-31 |
| RIA KIT FOR TRYPSIN (K791202) | Cis Radiopharmaceuticals, Inc. | 1979-11-05 |
Recalls involving this device
No recalls on record reference this clearance.