510(k) K052101
- Device
- C.F.A.S. (CALIBRATOR FOR AUTOMATED SYSTEMS) HBA1C
- Applicant
- Roche Diagnostics
- 510(k) number
- K052101
- Product code
- KRZ
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2005-08-26
- Date received
- 2005-08-03
- Regulation
- 864.8165
- Classification name
- Calibrator For Hemoglobin And Hematocrit Measurement
- Medical specialty
- Hematology
- Review panel
- Clinical Chemistry
- Device class
- 2
- Clearance type
- Abbreviated
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- THERESA M AMBROSE
- Address
- 9115 Hague Rd. Indianapolis IN US 46250 46250
FDA Registration Numbers#
- 1064608
- 2915274
- 9610126
- 3014150341
- 2432235
- 3007603826
- 3023162659
- 3016438761
- 1219029
- 2182501
- 2050010
- 1064130
- 2221819
- 1950302
- 2050012
- 3000148879
- 3005333358
- 3003741796
Source Documents#
Other 510(k) Records For Product Code KRZ #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K041130 | CDS HEMATOLOGY CALIBRATOR (CDS CAL) | Clinical Diagnostic Solutions, Inc. | 2004-06-10 |
| K962864 | THB CAL STANDARD FOR IL CO-OXIMETERS/OXIMETERS | Alko Diagnostic Corp. | 1996-12-18 |
| K951071 | ALKO SLOPE THB SOLUTION FOR CORNING 280, 288 AND 2500 ANALYZERS | Alko Diagnostic Corp. | 1995-07-24 |
| K902892 | CELL-DYN CALIBRATOR | Unipath , Ltd. | 1990-09-10 |
| K896921 | RAICHEM TM HEMOGLOBIN CALIBRATOR | Reagents Applications, Inc. | 1990-01-25 |
| K893984 | HGB-CAL SET/MULTIPLE | R&D Systems, Inc. | 1989-08-15 |
| K883703 | MSI-CAL 7 | Medical Specialties, Inc. | 1988-11-22 |
| K883850 | MSI-CAL 16 | Medical Specialties, Inc. | 1988-11-22 |
| K883851 | MSI-CAL 8 | Medical Specialties, Inc. | 1988-11-22 |
| K882600 | HEMOCUE HEMOGLOBIN CALIBRATOR | React and Co. | 1988-07-18 |
| K873832 | REAGENTS FOR USE ON CONTRAVES DC300, DC500, AL801 | In Vitro Diagnostics, Inc. | 1987-11-23 |
| K871283 | CYANMETHEMOGLOBIN STANDARD | U. S. Diagnostics, Inc. | 1987-04-15 |
| K854166 | HEMATOLOGY CALIBRATOR CONTROL | Interscience Diagnostics, Inc. | 1986-03-12 |
| K842668 | LIQUI-HEME HEMOGLOBIN CALIBRATORS | Biodiagnostic Intl | 1985-03-05 |
| K843695 | QCA HEMOGLOBIN KIT | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1984-12-17 |
Legacy Summary#
summary
FDA Review#
Decision Summary