510(k) K885227
- Device
- Clinistat Hemoglobin Reagent Test
- Applicant
- HERAEUS KULZER, INC.
- 510(k) number
- K885227
- Product code
- KHG
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1989-02-24
- Date received
- 1988-12-20
- Regulation
- 864.7500
- Classification name
- Whole Blood Hemoglobin Determination
- Medical specialty
- Hematology
- Review panel
- Hematology
- Device class
- 2
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Contact
- ROSANNE M SAVOL
- Address
- Diagnostics Division P.O. Box 70 Elkhart IN US 46515 46515
FDA Registration Numbers#
- 3013660430
- 1825740
- 9610126
- 3006198300
- 3004838836
- 3003795116
- 1318354
- 1616487
- 1827821
Source Documents#
510(k) summary PDF not indicated by FDA
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| K872653 | EASY-TEST HEMOGLOBIN (HGB) ITEM #16685 | Em Diagnostic Systems, Inc. | 1987-07-23 |
| K870363 | HAEMOGLOBIN REAGENT - CYANMETHAEMOGLOBIN METHOD | Trace Scientific , Ltd. | 1987-03-16 |
| K863104 | TOTAL HEMOGLOBIN | J. D. Assoc. | 1986-09-04 |
| K862641 | U.S. DIAGNOSTIC INC. HEMOGLOBIN TEST (DRY PACK) | U. S. Diagnostics, Inc. | 1986-08-21 |