510(k) K061979 ยท JKA Tubes, Vials, Systems, Serum Separators, Blood Collection
MODIFICATION TO MYALLERGY TEST
| Applicant | Immunetech Corporation, Menlo Park CA, US |
| Decision | Substantially Equivalent, Sep 22, 2006 |
| Received | Jul 13, 2006 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K061979
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| 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 | None listed |
| 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 | None listed |
| 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 | None listed |
| 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 | None listed |
| 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 | None listed |
| 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 | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.