Analytichem USA, Inc.
Winslow, ME, US
ANALYTICHEM USA, INC. appears in FDA device records in Winslow, ME. FDA records list no 510(k) clearances, no PMA records and one registered establishment. As of , FDA records show 2 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
FDA records under these names
1 nameFDA records resolved to Analytichem USA, Inc. carry these names as well, as FDA wrote them. Each is the firm named on a registration, a 510(k), a PMA, a recall or an enforcement report that was joined to this company on a shared FDA identifier or on a matching name.
- Northeast Laboratory Services, Inc.enforcement report, recall
510(k) clearance history
No 510(k) clearance records for this company in the ingested FDA data.
No 510(k) clearance records in the ingested FDA data.
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 1210083 | 1210083 | ANALYTICHEM USA, INC. | 227 China Road, Winslow, ME 04901 US | 2026 | and 3 more, listed in full below |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- FMHContainer, Specimen, Sterile
- KZICulture Media, Enriched
- JSCCulture Media, General Nutrient Broth
- JSECulture Media, Multiple Biochemical Test
- JSHCulture Media, Non-Selective And Differential
- JSGCulture Media, Non-Selective And Non-Differential
- JSICulture Media, Selective And Differential
- JSJCulture Media, Selective And Non-Differential
- JSDCulture Media, Selective Broth
- JSFCulture Media, Single Biochemical Test
- JTODiscs, Strips And Reagents, Microorganism Differentiation
- PPMGeneral Purpose Reagent
- JCESolution, Isotonic
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-1314-2016 | NEL- GBS Medium (Broth 3 ml Fill 13 x 100 mm Screw Cap Tube Catalog No.: T8000; For the selective enrichment and screening of Beta-Hemolytic Streptococcus agalactiae (Group B Strep). | Product marketed without a 510 (k) | Class II | Terminated | |
| Z-1313-2016 | NEL GBS Medium 20 ml in 100x15mm plate (Standard Petri Dish) Catalog No.: P8000; For the selective enrichment and screening of Beta-Hemolytic Streptococcus agalactiae (Group B Strep). | Product marketed without a 510 (k) | Class II | Terminated |
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain