510(k) K801771
- Device
- ALPHA-THAL SCREEN 20 TEST KIT & 100 KIT
- Applicant
- ISOLAB, INC.
- 510(k) number
- K801771
- Product code
- LGL
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1981-01-16
- Date received
- 1980-07-28
- Regulation
- 864.7500
- Classification name
- Assay, Bart's, Hemoglobin
- Medical specialty
- Hematology
- Review panel
- Hematology
- Device class
- 2
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Address
- 803 N. Front St. Suite 3 Mchenry IL US 60050 60050
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code LGL #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K810976 | ALPHA-THAL SCREEN TM CONTROL | Isolab, Inc. | 1981-05-29 |
Legacy Summary#
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FDA Review#
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