Company ยท US
Immunetech Inc
FDA 510(k) clearances and medical device recalls filed under this name, 2002 to 2006. Name variants (Inc, Corp, punctuation) are merged.
4510(k) clearances (0 in 12 months)
6recalls (0 in 12 months)
6recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Sep 22, 2006 | K061979 | MODIFICATION TO MYALLERGY TEST Immunetech Corporation | JKA |
| Dec 19, 2003 | K032251 | IMMUNETECH TOTAL IGE SYSTEM Immunetech Corporation | DGC |
| Sep 19, 2002 | K021698 | MY ALLERGY TEST Immunetech Corporation | JKA |
| Apr 17, 2002 | K020387 | MYALLERGYTEST SYSTEM Immunetech Corporation | DHB |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 25, 2011 | Immunetech Inc ImmuneTech brand MyAllergyTest, Specimen Collection Kit, Part No.
8024, Provider Pack: 5 test,
Product is manufactured distributed by ImmuneTech, Inc., Foster City, CA; but the
non-sterile al Terminated |
JKA | K021698 K061979 |
| Nov 25, 2011 | Immunetech Inc ImmuneTech brand MyAllergyTest, Specimen Collection Kit, Part No.
8021, Screening Pack: 100 test (with lancet & capillary),
Product is manufactured distributed by ImmuneTech, Inc., Foster City, Terminated |
JKA | K021698 K061979 |
| Nov 25, 2011 | Immunetech Inc ImmuneTech brand MyAllergyTest, Specimen Collection Kit, Part No.
8015, Screening Pack: 50 test (with lancet),
Product is manufactured distributed by ImmuneTech, Inc., Foster City, CA; but the Terminated |
JKA | K021698 K061979 |
| Nov 25, 2011 | Immunetech Inc ImmuneTech brand MyAllergyTest, Specimen Collection Kit, Part No.
8014, Provider Pack: 10 test (without lancet),
Product is manufactured distributed by ImmuneTech, Inc., Foster City, CA; but the Terminated |
JKA | K021698 K061979 |
| Nov 25, 2011 | Immunetech Inc ImmuneTech brand MyAllergyTest, Specimen Collection Kit, Part No.
8013, Provider Pack: 10 test (with lancet),
Product is manufactured distributed by ImmuneTech, Inc., Foster City, CA; but the Terminated |
JKA | K021698 K061979 |
| Nov 25, 2011 | Immunetech Inc ImmuneTech brand MyAllergyTest, Specimen Collection Kit, Part No.
8001; Individually Packaged Kit,
Product is manufactured distributed by ImmuneTech, Inc., Foster City, CA; but the
non-steri Terminated |
JKA | K021698 K061979 |