FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
DSL 17A-OH PROGERSTERONE (DSL #6800)
K Number: K894265
·
Decision Sep 7, 1989
Classifications
1
FEI Numbers
22
Registration Numbers
22
Same Product Code
18
Applicant Total
94
Review Days
77
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Basic Information
- Device Name
- DSL 17A-OH PROGERSTERONE (DSL #6800)
- K Number
- K894265
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 862.1395
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Applicant
- Diagnostic Systems Laboratories, Inc.
- Date Received
- June 22, 1989
- Decision Date
- September 7, 1989
- Product Code
- JLX
- Advisory Committee
- Clinical Chemistry
- Review Advisory Committee
- CH
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| JLX | Radioimmunoassay, 17-Hydroxyprogesterone | FDA class 1 | Clinical Chemistry |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (JLX), ordered by most recent decision date.
GSP NEONATAL 17A-OH-PROGESTERONE KIT MODEL: 3305-001U
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AUTODELFIA NEONATAL 17A-OH-PROGESTERONE KIT
FDA 510(k)
FDA Class 1
·Clinical Chemistry
ENZYME IMMUNOASSAY FOR THE DETECTION OF SALIVARY 17-A-HYDROXYPROGESTERONE
FDA 510(k)
FDA Class 1
·Clinical Chemistry
ACCUWELL 17-ALPHA-HYDROXYPROESTERONE ENZYME IMMUNOASSAY WITH MODELS 6015XX-ECAH
FDA 510(k)
FDA Class 1
·Clinical Chemistry
MODIFICATION TO: AUTODELFIA NEONATAL 17A-OH-PROGESTERONE L KIT
FDA 510(k)
FDA Class 1
·Clinical Chemistry
DELFIA NEONATAL 17A-OH-PROGESTERONE KIT
FDA 510(k)
FDA Class 1
·Clinical Chemistry
Other Clearances by Diagnostic Systems Laboratories, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K061758 | ACTIVE RENIN IRMA | Jul 28, 2006 | Substantially Equivalent |
| K020945 | AXSYM INTACT PTH, MODEL 2G06 | May 31, 2002 | Substantially Equivalent |
| K020128 | ACTIVE FREE BETA-HCG ELISA, MODEL DSL-10-8500 | Mar 1, 2002 | Substantially Equivalent |
| K002128 | ACTIVE INHIBIN-A ELISA, MODEL DSL-10-28100 | Dec 5, 2000 | Substantially Equivalent |
| K001086 | FREE TESTOSTERONE ENZYME IMMUNOASSAY, MODEL DSL-10-4900 | May 18, 2000 | Substantially Equivalent |
| K990138 | DSL ACTIVE AFP ELISA, MODEL DSL-10-8400 | Jun 21, 1999 | Substantially Equivalent |
| K981871 | C-REACTIVE PROTEIN ELISA, MODEL NUMBER DSL-10-42100 | Nov 9, 1998 | Substantially Equivalent |
| K973243 | ACTIVE PSA ELISA (DSL-10-9700) | Aug 3, 1998 | Substantially Equivalent |
| K973244 | ACTIVE PSA IRMA (DSL-9700) | Aug 3, 1998 | Substantially Equivalent |
| K981607 | ACTIVE RENIN IRMA MODEL NUMBER DSL-25100 | May 27, 1998 | Substantially Equivalent |