Uibc for Discreet Random Access Analyzer
FDA 510(k) K932871 · Catachem, Inc.
510(k) numberK932871
Submission
- Device name
- Uibc for Discreet Random Access Analyzer
- Applicant
- Catachem, Inc.
Bridgeport, CT, US - Received
- June 14, 1993
- Decision date
- September 8, 1993
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- CFM – Bathophenanthroline, Colorimetry, Iron (Non-Heme)
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 862.1410
- Specialty
- Clinical Chemistry
Other 510(k)s with product code CFM
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K984119 | Wako L-Type Fe, Wako L-Type CalibratorCFM · Traditional | Wako Chemicals USA, Inc. | 01/15/1999SE |
| K981581 | IronCFM · Traditional | Abbott Laboratories | 06/08/1998SE |
| K913705 | Abbott Qluickstart Iron Test, Item #5A29CFM · Traditional | Em Diagnostic Systems, Inc. | 10/09/1991SE |
| K912912 | Synermed Serum IRON-600 Reagent KitCFM · Traditional | Synermed, Inc. | 07/30/1991SE |
| K902918 | Synermed Serum Iron Reagent KitCFM · Traditional | Synermed, Inc. | 07/31/1990SE |
| K895047 | Clinistat Potassium Reagent TestCFM · Traditional | Heraeus Kulzer, Inc. | 10/17/1989SE |
| K891155 | Iron ReagentCFM · Traditional | Medical Analysis Systems, Inc. | 04/18/1989SE |
| K873120 | Abbott A-Gent Iron Reagent KitCFM · Traditional | Abbott Laboratories | 08/25/1987SE |
| K861602 | Total Iron Binding Capacity ProcedureCFM · Traditional | Data Medical Associates, Inc. | 05/23/1986SE |
| K854305 | Dart Iron & Iron Binding Capacity ReagentCFM · Traditional | Coulter Electronics, Inc. | 11/12/1985SE |
More from Coulter Electronics, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K062503 | Catachem, Inc., Bile Acids Reagents And/Or Bile Acids Test KitKWW · Traditional | 01/19/2007SE |
| K945408 | 340-CHLORIDE for Discrete Random Access AnalyzerCHJ · Traditional | 02/22/1995SE |
| K903341 | MagnesiumJGJ · Traditional | 08/22/1990SE |
| K902326 | Amylase for Manual/Automated ApplicationsJFJ · Traditional | 07/31/1990SE |
| K902877 | Total Iron for Manual/AutomatedJIY · Traditional | 07/27/1990SE |
| K895748 | Bicarbonate for Manual/Automated ApplicationsKHS · Traditional | 12/21/1989SE |
| K895821 | Uric Acid for Manual/Automated ApplicationsKNK · Traditional | 12/05/1989SE |
| K894715 | Creatine Kinase for Manual/Automated ApplicationsCGS · Traditional | 11/08/1989SE |
| K894476 | Calcium (Arsenazo III) for Manual/Auto ApplicationCJY · Traditional | 10/12/1989SE |
| K894389 | Creatinine for Manual or Automated ApplicationsGGX · Traditional | 10/12/1989SE |
Questions and answers
When was Uibc for Discreet Random Access Analyzer cleared by the FDA?
Uibc for Discreet Random Access Analyzer (K932871) received a 510(k) decision of Substantially Equivalent on September 8, 1993, 86 days after the submission was received.
What is the product code of K932871?
The FDA product code is CFM – Bathophenanthroline, Colorimetry, Iron (Non-Heme), a Class I (low risk) device regulated under 21 CFR 862.1410.