Ai-Photodiagnostic
FDA 510(k) K940004 · Pharmarceutical Discovery Corp.
510(k) numberK940004
Submission
- Device name
- Ai-Photodiagnostic
- Applicant
- Pharmarceutical Discovery Corp.
Elmsford, NY, US - Received
- January 3, 1994
- Decision date
- August 4, 1995
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- CIB – Radioimmunoassay, Angiotensin I And Renin
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.1085
- Specialty
- Clinical Chemistry
Other 510(k)s with product code CIB
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K123763 | Ids Isys Direct Renin Assay, Ids Isys Direct Renin Control Set, and Ids Isys Direct…CIB · Traditional | Immunodiagnostic Systems , Ltd. | 12/24/2013SE |
| K121944 | Liaison Direct Renin Liaison Control Direct Renin Liaison Endocrinology DiluentCIB · Traditional | DiaSorin, Inc. | 01/01/2013SE |
| K062120 | Cisbio Renin Ria TestCIB · Traditional | Cis Bio International | 03/30/2007SE |
| K061758 | Active Renin IrmaCIB · Special | Diagnostic Systems Laboratories, Inc. | 07/28/2006SE |
| K011128 | Nichols Advantage Direct Renin (Calibrators, Calibration Verifiers, Controls, and Sample…CIB · Traditional | Nichols Institute Diagnostics | 09/06/2001SE |
| K981607 | Active Renin Irma Model Number DSL-25100CIB · Traditional | Diagnostic Systems Laboratories, Inc. | 05/27/1998SE |
| K954299 | Buhlmann Angiostensin II RiaCIB · Traditional | Buhlmann Laboratories AG | 10/19/1995SE |
| K925998 | Active Renin Immunoradiometric AssayCIB · Traditional | Nichols Institute Diagnostics | 01/06/1993SE |
| K850054 | Rianen Angiotensin I Radioimmunoassay KiCIB · Traditional | E.I. Dupont DE Nemours & Co., Inc. | 03/29/1985SE |
| K842966 | Renin Radioimmunoassay Test KitCIB · Traditional | Serono Diagnostics, Inc. | 10/11/1984SE |
Questions and answers
When was Ai-Photodiagnostic cleared by the FDA?
Ai-Photodiagnostic (K940004) received a 510(k) decision of Substantially Equivalent on August 4, 1995, 578 days after the submission was received.
What is the product code of K940004?
The FDA product code is CIB – Radioimmunoassay, Angiotensin I And Renin, a Class II (moderate risk) device regulated under 21 CFR 862.1085.