Compur M-1000 Mini-Photometer
FDA 510(k) K800059 · Miles Laboratories, Inc.
510(k) numberK800059
Submission
- Device name
- Compur M-1000 Mini-Photometer
- Applicant
- Miles Laboratories, Inc.
Mchenry, IL, US - Received
- January 10, 1980
- Decision date
- April 4, 1980
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- KHG – Whole Blood Hemoglobin Determination
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 864.7500
- Specialty
- Hematology
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| K020138 | Stat-Site MHGB Meter, Stat-Site MHGB Meter Card Holder, Stat-Site MHGB Test Cards…KHG · Special | Gds Technology | 02/11/2002SE |
| K001462 | Careside HemoglobinKHG · Traditional | Careside, Inc. | 08/21/2000SE |
| K994073 | Hemosite Test SystemKHG · Traditional | Gds Technology, LLC | 01/14/2000SE |
| K973649 | Hemosite Test SystemKHG · Traditional | Gds Technology, LLC | 08/31/1998SE |
| K953221 | Abbott Vision Hemoglobin (Modification)KHG · Traditional | Abbott Laboratories | 09/29/1995SE |
| K934064 | Reflotron Hemoglobin Test TabsKHG · Traditional | Boehringer Mannheim Corp. | 12/06/1993SE |
| K895101 | Biotrack Hemoglobin Test CartridgeKHG · Traditional | Biotrack, Inc. | 10/10/1989SE |
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| 510(k) | Device | Decision |
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| 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 Compur M-1000 Mini-Photometer cleared by the FDA?
Compur M-1000 Mini-Photometer (K800059) received a 510(k) decision of Substantially Equivalent on April 4, 1980, 85 days after the submission was received.
What is the product code of K800059?
The FDA product code is KHG – Whole Blood Hemoglobin Determination, a Class II (moderate risk) device regulated under 21 CFR 864.7500.