Seralyzer Hemoglobin Calibrators
FDA 510(k) K822046 · Miles Laboratories, Inc.
510(k) numberK822046
Submission
- Device name
- Seralyzer Hemoglobin Calibrators
- Applicant
- Miles Laboratories, Inc.
Mchenry, IL, US - Received
- July 12, 1982
- Decision date
- July 30, 1982
- 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 |
|---|---|---|
| K880605 | Labeling Change for Cutter Pureflo Plus IV FilterFPB · Traditional | 05/26/1988SE |
| K874909 | Micro-Bumintest Reagent TabletsJIR · Traditional | 04/28/1988SE |
| K875079 | Modified Seralyzer Alt/Sgpt Reag. Strips & ModuleCKA · Traditional | 04/05/1988SE |
| K871835 | Glucometer QC Blood Meter, Ames Gluco System PrintCGA · Traditional | 12/22/1987SE |
| K872120 | Seralyzer III Blood Chemistry AnalyzerJJF · Traditional | 10/28/1987SE |
| K873304 | Clinitek Auto 2000 Reagent Cassette (Leukocytes)LJX · Traditional | 09/11/1987SE |
| K872634 | Cutter Pureflo Plus IV FilterFPB · Traditional | 08/04/1987SE |
| K870214 | Modified Saltex Reagent StripsCHK · Traditional | 06/29/1987SE |
| K870752 | Seralyzer Ldh/Total Bilirubin/Triglycerides StripsCFJ · Traditional | 04/14/1987SE |
| K865053 | Sera-Tek Microsomal Antibody TestJZO · Traditional | 02/18/1987SE |
Questions and answers
When was Seralyzer Hemoglobin Calibrators cleared by the FDA?
Seralyzer Hemoglobin Calibrators (K822046) received a 510(k) decision of Substantially Equivalent on July 30, 1982, 18 days after the submission was received.
What is the product code of K822046?
The FDA product code is KRZ – Calibrator For Hemoglobin And Hematocrit Measurement, a Class II (moderate risk) device regulated under 21 CFR 864.8165.