510(k) K993825 ยท JCN Control, Cell Counter, Normal And Abnormal
PARA TECH PLUS RETICS
| Applicant | Streck Laboratories, Inc., Omaha NE, US |
| Decision | Substantially Equivalent, Nov 30, 1999 |
| Received | Nov 12, 1999 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K993825
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 3, 2025 | Siemens Healthcare Diagnostics, Inc. ADVIA 120/2120/2120i 3-in-1 TESTpoint Control (ABN1 Control) Open, Classified |
JCN | None listed |
| Jul 3, 2025 | Siemens Healthcare Diagnostics, Inc. ADVIA 120/2120/2120i 3-in-1 TESTpoint Control (Norm Control) Open, Classified |
JCN | None listed |
| Jul 3, 2025 | Siemens Healthcare Diagnostics, Inc. ADVIA 120/2120/2120i 3-in-1 TESTpoint Control (ABN2 Control) Open, Classified |
JCN | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.