510(k) K832011
- Device
- AMERI CLEAR
- Applicant
- STEPHENS SCIENTIFIC
- 510(k) number
- K832011
- Product code
- KEM
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1983-08-12
- Date received
- 1983-06-23
- Regulation
- 864.4010
- Classification name
- Agent, Clearing
- Medical specialty
- Pathology
- Review panel
- Hematology
- Device class
- 1
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Address
- 803 N. Front St. Suite 3 Mchenry IL US 60050 60050
FDA Registration Numbers#
- 3004594181
- 3007496191
- 1618982
- 9610140
- 3016764932
- 3009963993
- 9680745
- 3039353646
- 1045125
- 3026040791
- 3017498820
- 3033524192
- 9610126
- 1419341
- 3003795116
- 1640981
- 3010602043
- 3006979687
- 3003423869
- 1419699
- 3009189893
- 3017889386
- 9610566
- 1063851
- 2025606
- 9610099
- 3010692993
- 3017970519
- 1831638
- 3004973408
- 1831338
- 3008174888
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code KEM #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K881282 | XYLENE | Anatech, Ltd. | 1988-04-05 |
| K874461 | HEMO-SOL | Chem Pharm, Inc. | 1987-12-04 |
| K861490 | PERMACLEAR SOLUTION CAT. NO. 4950 | Helena Laboratories | 1986-05-06 |
| K855109 | CLEARENE, CLEARING AGENT | Surgipath Medical Industries, Inc. | 1986-01-07 |
| K853694 | XYLENE SUBSTITUTE | Lerner Laboratories, Inc. | 1985-10-22 |
| K854083 | XYLENE SUBSTITUTE MONTANT | Lerner Laboratories, Inc. | 1985-10-22 |
| K842861 | PRO-PAR CLEARANT | Anatech, Ltd. | 1984-08-21 |
| K842721 | LIMONENE | E K Ind., Inc. | 1984-08-03 |
| K832451 | CLEAR-RITE 3 | Richard-Allan Medical Ind., Inc. | 1983-08-12 |
| K830627 | CLARIFIER-RICHARD-ALLAN | Richard-Allan Medical Ind., Inc. | 1983-03-24 |
| K822784 | HEMO-DE | Pmp Industries | 1982-11-05 |
| K812846 | CLEAR-RITE II | Richard-Allan Medical Ind., Inc. | 1981-10-29 |
| K812847 | XYLENE | Richard-Allan Medical Ind., Inc. | 1981-10-29 |
| K811798 | CLEAR-RITE | Richard-Allan Medical Ind., Inc. | 1981-07-28 |
Legacy Summary#
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FDA Review#
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