Reagents for Use on Contraves DC300, DC500, AL801
FDA 510(k) K873832 · In Vitro Diagnostics, Inc.
510(k) numberK873832
Submission
- Device name
- Reagents for Use on Contraves DC300, DC500, AL801
- Applicant
- In Vitro Diagnostics, Inc.
Shelton, CT, US - Received
- September 21, 1987
- Decision date
- November 23, 1987
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- KRZ – Calibrator For Hemoglobin And Hematocrit Measurement
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 864.8165
- Specialty
- Hematology
Other 510(k)s with product code KRZ
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K052101 | C.F.A.S. (Calibrator for Automated Systems) HBA1CKRZ · Abbreviated | Roche Diagnostics | 08/26/2005SE |
| K041130 | CDS Hematology Calibrator (CDS Cal)KRZ · Abbreviated | Clinical Diagnostic Solutions, Inc. | 06/10/2004SE |
| K962864 | THB Cal Standard for Il Co-Oximeters/OximetersKRZ · Traditional | Alko Diagnostic Corp. | 12/18/1996SE |
| K951071 | Alko Slope THB Solution for Corning 280, 288 and 2500 AnalyzersKRZ · Traditional | Alko Diagnostic Corp. | 07/24/1995SE |
| K902892 | Cell-Dyn CalibratorKRZ · Traditional | Unipath , Ltd. | 09/10/1990SE |
| K896921 | Raichem TM Hemoglobin CalibratorKRZ · Traditional | Reagents Applications, Inc. | 01/25/1990SE |
| K893984 | Hgb-Cal Set/MultipleKRZ · Traditional | R&D Systems, Inc. | 08/15/1989SE |
| K883851 | Msi-Cal 8KRZ · Traditional | Medical Specialties, Inc. | 11/22/1988SE |
| K883850 | Msi-Cal 16KRZ · Traditional | Medical Specialties, Inc. | 11/22/1988SE |
| K883703 | Msi-Cal 7KRZ · Traditional | Medical Specialties, Inc. | 11/22/1988SE |
More from Medical Specialties, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K896867 | Thyroid Stimulating Hormone-Eia-XtJLW · Traditional | 02/23/1990SE |
| K896866 | Luteinizing Hormone-Eia-XtCEP · Traditional | 02/13/1990SE |
| K896863 | Digoxin-Eia-XtKXT · Traditional | 02/13/1990SE |
| K896865 | Vitro T4-EIA-XTKLI · Traditional | 01/30/1990SE |
| K896925 | T Uptake Enzyme Immunoassay Crimped Tube KitKHQ · Traditional | 01/18/1990SE |
| K896864 | Follicle Stimulating Hormone-Eia-XtCGJ · Traditional | 01/11/1990SE |
| K871188 | Lithium Internal Standard 1500 Meq/L #60086JIS · Traditional | 05/28/1987SE |
| K871187 | Lithium Internal Standard 3000 Meq/L #60084JIS · Traditional | 05/28/1987SE |
| K871186 | Cesium Diluent 1.5 Mmol Cs/L #60087JIS · Traditional | 05/28/1987SE |
| K871185 | Lithium Internal Standard 1 Meq/L #60085JIS · Traditional | 05/28/1987SE |
Questions and answers
When was Reagents for Use on Contraves DC300, DC500, AL801 cleared by the FDA?
Reagents for Use on Contraves DC300, DC500, AL801 (K873832) received a 510(k) decision of Substantially Equivalent on November 23, 1987, 63 days after the submission was received.
What is the product code of K873832?
The FDA product code is KRZ – Calibrator For Hemoglobin And Hematocrit Measurement, a Class II (moderate risk) device regulated under 21 CFR 864.8165.