Raichem Prealbumin Spia
FDA 510(k) K972812 · Hemagen Diagnostics, Inc.
510(k) numberK972812
Submission
- Device name
- Raichem Prealbumin Spia
- Applicant
- Hemagen Diagnostics, Inc.
Waltham, MA, US - Received
- July 28, 1997
- Decision date
- August 28, 1997
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- DDS – Prealbumin, Fitc, Antigen, Antiserum, Control
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 866.5060
- Specialty
- Immunology
Other 510(k)s with product code DDS
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K964781 | Immage Immunochemistry System Prealbumin (Pab) ReagentDDS · Traditional | Beckman Instruments, Inc. | 05/09/1997SE |
| K934966 | SPQ Pal Control Level IIDDS · Traditional | Incstar Corp. | 01/11/1994SE |
| K854811 | Ics Pab Prealbumin Reagent Test KitDDS · Traditional | Beckman Instruments, Inc. | 01/24/1986SE |
More from Beckman Instruments, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K041052 | Raichem Glucose UV (Liquid)CFR · Traditional | 06/30/2004SE |
| K041051 | Raichem Bun Rate Reagent (Liquid)CDQ · Traditional | 06/30/2004SE |
| K041009 | Raichem Calcium (Ocpc) Liquid ReagentCIC · Traditional | 06/25/2004SE |
| K031101 | Raichem Assayed Control Serum Level 1 & 2JJY · Abbreviated | 06/16/2003SE |
| K023784 | Raichem HDL Cholesterol Using Cantrol HDL Precipitating Tubes on the Cobas Mira AnaylzerLBR · Special | 12/24/2002SE |
| K022772 | Raichem Ldl-Cholesterol Direct ReagentMRR · Traditional | 09/17/2002SE |
| K022767 | Raichem Lipid CalibratorJIX · Special | 09/03/2002SE |
| K021194 | Raichem CRP High Sensitivity Test SystemDCK · Traditional | 07/29/2002SE |
| K022049 | Modification to Raichem Calcium ReagentCJY · Special | 07/19/2002SE |
| K012668 | Raichem Glucose UV ReagentCFR · Traditional | 10/15/2001SE |
Questions and answers
When was Raichem Prealbumin Spia cleared by the FDA?
Raichem Prealbumin Spia (K972812) received a 510(k) decision of Substantially Equivalent on August 28, 1997, 31 days after the submission was received.
What is the product code of K972812?
The FDA product code is DDS – Prealbumin, Fitc, Antigen, Antiserum, Control, a Class I (low risk) device regulated under 21 CFR 866.5060.