Raichem (TM) Spia (TM) - Acid Glycoprotein Reagent
FDA 510(k) K904175 · Reagents Applications, Inc.
510(k) numberK904175
Submission
- Device name
- Raichem (TM) Spia (TM) - Acid Glycoprotein Reagent
- Applicant
- Reagents Applications, Inc.
San Diego, CA, US - Received
- September 11, 1990
- Decision date
- November 13, 1990
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- LKL – Alpha-1-Acid-Glycoprotein, Antigen, Antiserum, Control
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 866.5420
- Specialty
- Immunology
Other 510(k)s with product code LKL
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K993441 | K-Assay ALPHA-1 AGLKL · Traditional | Kamiya Biomedical Co. | 11/24/1999SE |
| K964299 | N-Assay Tia Multi V-NlLKL · Traditional | Crestat Diagnostics, Inc. | 07/14/1997SE |
| K964257 | Immage Immunochemistry System ALPHA-1-ACID Glycoprotein (Aag) ReagentLKL · Traditional | Beckman Instruments, Inc. | 03/24/1997SE |
| K922417 | Al-Acid Glycoprotein Rid KitLKL · Traditional | The Binding Site, Ltd. | 08/20/1992SE |
| K884217 | Technicon DPA-1 Analyte Alpha 1 Acid GlycoproteinLKL · Traditional | Technicon Instruments Corp. | 11/04/1988SE |
| K873868 | ALPHA-1-ACID Glycoprotein (Orosomucoid)LKL · Traditional | Unipath , Ltd. | 10/20/1987SE |
| K862087 | Santest 1APLKL · Traditional | Scientific Sales Intl., Inc. | 12/03/1986SE |
| K861336 | Iap Plate TestLKL · Traditional | Scientific Sales Intl., Inc. | 04/25/1986SE |
| K841734 | Tago Fiffu-Gen, OrosomucoidLKL · Traditional | Tago, Inc. | 06/01/1984SE |
| K831960 | Test for Human Alpha One Acid Glyco-LKL · Traditional | Kent Laboratories, Inc. | 07/19/1983SE |
More from Kent Laboratories, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K982056 | Raichem CO2 ReagentKHS · Special | 06/24/1998SE |
| K972853 | Cholesterol Rapid Liquid ReagentCHH · Traditional | 09/24/1997SE |
| K922904 | Rai-Trol Fructosamine Serum Controls I and IIJJX · Traditional | 07/30/1992SE |
| K915191 | Rai-Trol Elevated Lipids ControlJJY · Traditional | 12/18/1991SE |
| K913398 | Raichem(Tm) Creatine Kinase-Mb ReagentCGS · Traditional | 09/25/1991SE |
| K911900 | Raichem Spia C3 ReagentCZW · Traditional | 05/09/1991SE |
| K911899 | Raichem Spia C4 ReagentDBI · Traditional | 05/09/1991SE |
| K911898 | Raichem(Tm) Spia(Tm) Haptoglobin ReagentDAD · Traditional | 05/08/1991SE |
| K905085 | Raichem GGT ReagentJQB · Traditional | 12/20/1990SE |
| K905084 | Raichem Creatine Kinase Reagent, Optimized UVCGS · Traditional | 12/20/1990SE |
Questions and answers
When was Raichem (TM) Spia (TM) - Acid Glycoprotein Reagent cleared by the FDA?
Raichem (TM) Spia (TM) - Acid Glycoprotein Reagent (K904175) received a 510(k) decision of Substantially Equivalent on November 13, 1990, 63 days after the submission was received.
What is the product code of K904175?
The FDA product code is LKL – Alpha-1-Acid-Glycoprotein, Antigen, Antiserum, Control, a Class I (low risk) device regulated under 21 CFR 866.5420.