510(k) K896206 ยท JKA Tubes, Vials, Systems, Serum Separators, Blood Collection
STATSPIN STATSAMPLER
| Applicant | Statspin Technologies, Norwood MA, US |
| Decision | Substantially Equivalent, Nov 22, 1989 |
| Received | Oct 26, 1989 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K896206
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 23, 2008 | StatSpin, Inc., dba Iris Sample Processing StatSampler 200 uL, Li Heparin (micro blood collector)
Ref: SS2H
Packed in Catalog Numbers:
SS2H (I vial), SS2H-06 (6 kits/case), CH2C-I0 (I0 vials/kit)
Intended for collection and processing of cap Terminated |
JKA | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.