Coat-A-Count Androstenedione Ria Kit
FDA 510(k) K844398 · Diagnostic Products Corp.
510(k) numberK844398
Submission
- Device name
- Coat-A-Count Androstenedione Ria Kit
- Applicant
- Diagnostic Products Corp.
Los Angeles, CA, US - Received
- November 13, 1984
- Decision date
- December 10, 1984
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- CIZ – Radioimmunoassay, Androstenedione
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 862.1075
- Specialty
- Clinical Chemistry
Other 510(k)s with product code CIZ
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K963002 | Active Androstenedione EiaCIZ · Traditional | Diagnostic Systems Laboratories, Inc. | 08/16/1996SE |
| K954755 | Coat-A-Count Direct AndrostenedioneCIZ · Traditional | Diagnostic Products Corp. | 11/29/1995SE |
| K934751 | Active Androstanediol GlucuronideCIZ · Traditional | Diagnostic Systems Laboratories, Inc. | 01/10/1994SE |
| K860559 | Androstenedione 125I Kit by RiaCIZ · Traditional | Immuchem Corp. | 03/14/1986SE |
| K854673 | DSL Androstenedione Ria (DSL # 4200)CIZ · Traditional | Diagnostic Systems Laboratories, Inc. | 01/22/1986SE |
| K854650 | DSL Active Androstenedione Ria (DSL #3800)CIZ · Traditional | Diagnostic Systems Laboratories, Inc. | 12/13/1985SE |
| K842960 | Androstenedione by RiaCIZ · Traditional | Radioassay Systems Laboratories, Inc. | 09/27/1984SE |
| K832452 | Androstenedione Test Set 125ICIZ · Traditional | Wien Laboratories, Inc. | 09/12/1983SE |
| K801729 | Androstenedione Radioimmunoassay KitCIZ · Traditional | Diagnostics Biochem Canada, Inc. | 10/31/1980SE |
More from Diagnostics Biochem Canada, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K063057 | Immulite/Immulite 1000, Immulite 2000 High Sensitivity CRPNQD · Abbreviated | 12/22/2006SE |
| K063045 | Immulite 2000, Immulite 2500 VancomycinLEH · Traditional | 12/05/2006SE |
| K060929 | Immulite 2500 Vitamin B12 Model L5KVB2-200 TEST,L5KVB6-600 Test, Immulite 2500 Folic…CDD · Special | 04/28/2006SE |
| K053533 | Immulite/Immulite 1000 Turbo Intact PTHCEW · Traditional | 02/03/2006SE |
| K034055 | Immulite 2500 Ck-Mb, 2500 Myoglobin, 2500 Stat Troponin IJHX · Special | 01/21/2004SE |
| K033234 | Immulite 2500 Automated Immunoassay AnalyzerDHA · Traditional | 12/12/2003SE |
| K032881 | Immulite/Immulite 1000 Total Testosterone and Immulite 2000 Total TestosteroneCDZ · Special | 10/10/2003SE |
| K023152 | Immulite 2000 Allergen-Specific IgeDHB · Abbreviated | 12/17/2002SE |
| K023304 | Immulite/Immulite 1000 Calcitonin, Model LKCL and Immulite 2000 Calcitonin, Model L2KCLJKR · Traditional | 12/09/2002SE |
| K022603 | Immulite 1000 Automated Immunoassay AnalyzerCEW · Special | 08/21/2002SE |
Questions and answers
When was Coat-A-Count Androstenedione Ria Kit cleared by the FDA?
Coat-A-Count Androstenedione Ria Kit (K844398) received a 510(k) decision of Substantially Equivalent on December 10, 1984, 27 days after the submission was received.
What is the product code of K844398?
The FDA product code is CIZ – Radioimmunoassay, Androstenedione, a Class I (low risk) device regulated under 21 CFR 862.1075.