510(k) K102419
- Device
- GSP NEONATAL IRT KIT (3306-001U)
- Applicant
- WALLAC OY, SUBSIDIARY OF PERKINELMER
- 510(k) number
- K102419
- Product code
- JNO
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2010-12-16
- Date received
- 2010-08-25
- Regulation
- 862.1725
- Classification name
- N-benzoyl-l-arginine Ethyl Ester (u.v.), Trypsin
- Medical specialty
- Clinical Chemistry
- Review panel
- Clinical Chemistry
- Device class
- 1
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- SUSAN K HAMANN
- Address
- 940 Winter St. Waltham MA US 02451 02451
FDA Registration Numbers#
- 8043909
Source Documents#
Other 510(k) Records For Product Code JNO #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K110274 | AUTODELFIA NEONATAL IRT KIT | Wallac Oy, A Subsidiary of Perkinelmer, Inc. | 2011-06-10 |
| K932406 | NUCLITRYP(TM)(I125)-HUMAN PANCREA CATH TRY RAD KIT | Nuclear Diagnostics, Inc. | 1993-12-02 |
| K883011 | MRI NEO-TRYP TRYPSIN RIA | Microbiological Research Corp. | 1989-04-26 |
| K861097 | TRYPSIN RIA KIT | Microanalytic Research, Inc. | 1986-05-29 |
| K811805 | TRYPIN (125I) RIA KIT | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1981-08-31 |
| K791202 | RIA KIT FOR TRYPSIN | Cis Radiopharmaceuticals, Inc. | 1979-11-05 |
Legacy Summary#
summary
FDA Review#
Decision Summary