C.F.A.S. (Calibrator for Automated Systems) HBA1C
FDA 510(k) K052101 · Roche Diagnostics
510(k) numberK052101
Submission
- Device name
- C.F.A.S. (Calibrator for Automated Systems) HBA1C
- Applicant
- Roche Diagnostics
Indianapolis, IN, US - Received
- August 3, 2005
- Decision date
- August 26, 2005
- Decision
- Substantially Equivalent (SESE)
- Type
- Abbreviated 510(k)
- Summary
- 510(k) summary available from FDA
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 |
|---|---|---|---|
| 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 |
| K882600 | Hemocue Hemoglobin CalibratorKRZ · Traditional | React and Co. | 07/18/1988SE |
More from React and Co.
| 510(k) | Device | Decision |
|---|---|---|
| K261686 | Elecsys Phospho-Tau (217P) PlasmaSET · Traditional | 08/19/2026SE |
| K252323 | cobas pulse blood glucose monitoring systemPZI · Dual Track | 06/12/2026SE |
| K252431 | Elecsys CalcitoninJKR · Traditional | 04/24/2026SE |
| K252280 | Elecsys Anti-SARS-CoV-2 SQVP · Traditional | 04/13/2026SE |
| K260049 | Elecsys Anti-HBc IgMSEI · Traditional | 04/07/2026SE |
| K260048 | Elecsys Anti-HAV IgMLOL · Traditional | 04/07/2026SE |
| K260046 | Elecsys Anti-HBc IISEI · Traditional | 04/07/2026SE |
| K260026 | Tina-quant Cardiac high sensitivity CRP IIINQD · Traditional | 04/02/2026SE |
| K253491 | ISE indirect K for Gen.2; ISE indirect Na for Gen.2; ISE indirect Cl for Gen.2; cobas…CEM · Traditional | 02/12/2026SE |
| K253490 | Glucose HK Gen.3; ONLINE DAT Methadone II; cobas pro integrated solutionsCFR · Traditional | 02/12/2026SE |
Questions and answers
When was C.F.A.S. (Calibrator for Automated Systems) HBA1C cleared by the FDA?
C.F.A.S. (Calibrator for Automated Systems) HBA1C (K052101) received a 510(k) decision of Substantially Equivalent on August 26, 2005, 23 days after the submission was received.
What is the product code of K052101?
The FDA product code is KRZ – Calibrator For Hemoglobin And Hematocrit Measurement, a Class II (moderate risk) device regulated under 21 CFR 864.8165.