510(k) K071649 ยท JIA Enzymatic Methods, Galactose
NEONATAL TOTAL GALACTOSE KIT; NEONTAL TOTAL GALACTOSE KIT, MODELS 3029-0010 AND 3029-110B
| Applicant | Wallac OY, Waltham MA, US |
| Decision | Substantially Equivalent, Aug 7, 2008 |
| Received | Jun 18, 2007 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K071649
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 16, 2013 | Perkinelmer NEONATAL TOTAL GALACTOSE KIT
Product Numbers: 3029-0010, 3029-001B.
This kit is intended for the quantitative determination of total galactose (galactose and gal Terminated |
JLA | None listed |
| Jan 16, 2013 | Perkinelmer DBS MICROPLATE, TRUNCATED V-BOTTOMED
Product Number: 3033-0010 Terminated |
None listed | |
| Jan 16, 2013 | Perkinelmer Microplate, truncated V-bottomed lots included in the
above listed products
Product Number: 1380 5465.
DBS Microplate is a general purpose 96 well microplate used in the preparation and exami Terminated |
None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.