510(k) K062534
- Device
- ENZYME IMMUNOASSAY FOR THE DETECTION OF SALIVARY 17-A-HYDROXYPROGESTERONE
- Applicant
- DRG INTL., INC.
- 510(k) number
- K062534
- Product code
- JLX
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2008-01-29
- Date received
- 2006-08-29
- Regulation
- 862.1395
- Classification name
- Radioimmunoassay, 17-hydroxyprogesterone
- Medical specialty
- Clinical Chemistry
- Review panel
- Clinical Chemistry
- Device class
- 1
- Clearance type
- Traditional
- Statement or summary
- Statement
- Third party reviewed
- No
Applicant Contact#
- Contact
- Gary Lehnus
- Address
- 150 Cherry Ln. Rd. East Stroudsburg PA US 18301 18301
FDA Registration Numbers#
- 3022178699
- 8010132
- 3002800697
- 3007361513
- 2029372
- 9610126
- 2245285
- 8031673
- 2032839
- 3050015
- 2020726
- 3003741796
- 3003559191
- 8043909
- 3009335633
- 3005542422
- 3005529799
- 9710337
- 9612316
- 1222302
- 2133982
- 3007118747
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code JLX #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K100682 | GSP NEONATAL 17A-OH-PROGESTERONE KIT MODEL: 3305-001U | Wallac OY | 2010-07-23 |
| K081922 | AUTODELFIA NEONATAL 17A-OH-PROGESTERONE KIT | Wallac OY | 2009-04-16 |
| K060452 | ACCUWELL 17-ALPHA-HYDROXYPROESTERONE ENZYME IMMUNOASSAY WITH MODELS 6015XX-ECAH | Neo-Genesis | 2007-03-13 |
| K050960 | MODIFICATION TO: AUTODELFIA NEONATAL 17A-OH-PROGESTERONE L KIT | Wallac OY | 2005-07-11 |
| K042425 | AUTODELFIA NEONATAL 17A-OH-PROGESTERONE KIT | Wallac OY | 2004-09-30 |
| K042424 | DELFIA NEONATAL 17A-OH-PROGESTERONE KIT | Wallac OY | 2004-09-30 |
| K973350 | BIO-RAD MICROPLATE 17-HYDROXYPROGESTERONE TEST | Bio-Rad | 1998-02-09 |
| K934178 | ACCUSCREEN 17-HYDROXYPROGESTERONE | Neometrics, Inc. | 1995-03-30 |
| K940233 | NEOSCREEN ELISA HYDROXYPROGESTERONE | Pantex | 1994-12-28 |
| K943148 | DSL ACTIVE 17A-OH PROGESTERONE RIA (DSL 5000) | Diagnostic Systems Laboratories, Inc. | 1994-11-10 |
| K912026 | DELFIA(R) 17 -OH-PROGESTERON KIT | Pharmacia Diagnostics, Inc. | 1991-06-25 |
| K911839 | NEONATAL BLOOD SPOT TEST 17-HYDROXPROG RADIO KIT | Pantex, Div. Bio-Analysis, Inc. | 1991-06-18 |
| K894265 | DSL 17A-OH PROGERSTERONE (DSL #6800) | Diagnostic Systems Laboratories, Inc. | 1989-09-07 |
| K885198 | 17-ALPHA-HYDROXYPROGESTERONE (17-OH-P) NEO. RIA | Icn Biomedicals, Inc. | 1989-02-23 |
| K874782 | COAT-A-COUNT NEONATAL 17-ALPHA HYDROXPROG RIA KIT | Diagnostic Products Corp. | 1988-02-11 |
Legacy Summary#
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FDA Review#
Decision Summary