Agent, Clearing
Regulation 864.4010
0510(k)s in 12 months (15 all time)
0recalls in 12 months (0 all time)
0recalls that name a 510(k)
Top companies in KEM
| Company | 510(k)s | Recalls |
|---|---|---|
| Richard-Allan Medical Ind., Inc. | 5 | 0 |
| Anatech, Ltd. | 2 | 0 |
| Lerner Laboratories, Inc. | 2 | 0 |
| Chem Pharm, Inc. | 1 | 0 |
| E K Ind., Inc. | 1 | 0 |
| Helena Laboratories | 1 | 0 |
| Pmp Industries | 1 | 0 |
| Stephens Scientific | 1 | 0 |
| Surgipath Medical Industries, Inc. | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Apr 5, 1988 | K881282 | XYLENE Anatech, Ltd. | KEM |
| Dec 4, 1987 | K874461 | HEMO-SOL Chem Pharm, Inc. | KEM |
| May 6, 1986 | K861490 | PERMACLEAR SOLUTION CAT. NO. 4950 Helena Laboratories | KEM |
| Jan 7, 1986 | K855109 | CLEARENE, CLEARING AGENT Surgipath Medical Industries, Inc. | KEM |
| Oct 22, 1985 | K854083 | XYLENE SUBSTITUTE MONTANT Lerner Laboratories, Inc. | KEM |
| Oct 22, 1985 | K853694 | XYLENE SUBSTITUTE Lerner Laboratories, Inc. | KEM |
| Aug 21, 1984 | K842861 | PRO-PAR CLEARANT Anatech, Ltd. | KEM |
| Aug 3, 1984 | K842721 | LIMONENE E K Ind., Inc. | KEM |
| Aug 12, 1983 | K832451 | CLEAR-RITE 3 Richard-Allan Medical Ind., Inc. | KEM |
| Aug 12, 1983 | K832011 | AMERI CLEAR Stephens Scientific | KEM |
| Mar 24, 1983 | K830627 | CLARIFIER-RICHARD-ALLAN Richard-Allan Medical Ind., Inc. | KEM |
| Nov 5, 1982 | K822784 | HEMO-DE Pmp Industries | KEM |
| Oct 29, 1981 | K812847 | XYLENE Richard-Allan Medical Ind., Inc. | KEM |
| Oct 29, 1981 | K812846 | CLEAR-RITE II Richard-Allan Medical Ind., Inc. | KEM |
| Jul 28, 1981 | K811798 | CLEAR-RITE Richard-Allan Medical Ind., Inc. | KEM |
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