Hemoglobinometer
A Hemoglobinometer (product code GIG) is a dedicated photometric instrument used in hematology to measure the hemoglobin concentration in blood samples by quantifying light absorption at specific wavelengths, supporting rapid point-of-care or laboratory hemoglobin determination. This device is classified as FDA Class 2, indicating moderate risk, and requires 510(k) premarket notification. Regulated under 21 CFR 864.7500 in the Hematology specialty (HE), it is eligible for third-party review.
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Basic Information
- Product Code
- GIG
- Device Class
- FDA class 2
- Regulation Number
- 864.7500
- Medical Specialty
- Hematology
- Review Panel
- HE
- Submission Type
- 1
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 3 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K973995 | RANDOX BILIRUBIN | Dec 08, 1997 | Substantially Equivalent | Randox Laboratories, Ltd. |
| K933836 | HBM HEMOGLOBINOMETER | Mar 31, 1994 | Substantially Equivalent | Artel, Inc. |
| K771101 | HEMOGLOBIN ANALYZER & PERFORM. CHECK SET | Jul 21, 1977 | Substantially Equivalent | The Dow Chemical Co. |
FEI Numbers
This FDA classification entry is associated with 4 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 4 registration numbers. Click on an entry to view related FDA registrations.