Company ยท US
American Scientific Products
FDA 510(k) clearances and medical device recalls filed under this name, 1981 to 1986. Name variants (Inc, Corp, punctuation) are merged.
28510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| CDQ | Urease And Glutamic Dehydrogenase, Urea Nitrogen | 2 |
| CGA | Glucose Oxidase, Glucose | 2 |
| CGX | Alkaline Picrate, Colorimetry, Creatinine | 2 |
| GIE | Fibrometer | 2 |
| GMI | Antigen, Cf And / Or Id, Coccidioides Immitis | 2 |
| JJG | Analyzer, Chemistry, Centrifugal, For Clinical Use | 2 |
| GKL | Counter, Cell, Automated (Particle Counter) | 1 |
| GMD | Antisera, Latex Agglutination, Cryptococcus Neoformans | 1 |
| GMG | Antigen, Latex Agglutination, Coccidioides Immitis | 1 |
| GMJ | Antigens, Histoplasma Capsulatum, All | 1 |
| GTP | Exoenzymes, Multiple, Streptococcal | 1 |
| JSI | Culture Media, Selective And Differential | 1 |
| JTL | Plasma, Coagulase, Human, Horse And Rabbit | 1 |
| JTR | Kit, Quality Control For Culture Media | 1 |
| JZS | Electrophoresis Instrumentation | 1 |
| KDT | Container, Specimen Mailer And Storage, Sterile | 1 |
| KEO | Formulations, Paraffin, All | 1 |
| LEB | Mounting Media | 1 |
| LED | Stains, Chemical Solution | 1 |
| LHK | Antigen, Id, Candida Albicans | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Dec 24, 1986 | K864824 | INFECTIOUS TISSUE KIT American Scientific Products | |
| Oct 23, 1984 | K844042 | BLOOD DILUTION VIAL American Scientific Products | GKL |
| Jul 19, 1983 | K831634 | GLUCOSE REAGENT B6360-11 American Scientific Products | CGA |
| Jul 7, 1983 | K831626 | UREA NITROGEN-BUN-REAGENTS B6370-11A American Scientific Products | CDQ |
| Jul 7, 1983 | K831625 | UREA NITROGEN-BUN-REAGENTS B6360-12 American Scientific Products | CDQ |
| Jul 6, 1983 | K831628 | CREATININE REAGENTS B6370-13 American Scientific Products | CGX |
| Jul 6, 1983 | K831627 | CREATININE REAGENTS B6360-10 American Scientific Products | CGX |
| Jul 6, 1983 | K831624 | GLUCOSE REAGENT KITS-B6370-10A American Scientific Products | CGA |
| Jun 30, 1983 | K831571 | ROTOR American Scientific Products | JJG |
| Jun 30, 1983 | K831569 | REAGENT CUPS American Scientific Products | JJG |
| Dec 19, 1982 | K822799 | STREPTACOCCUS CO-AGGLUTINATION KIT American Scientific Products | GTP |
| Nov 5, 1982 | K822988 | COAGULASE PLASMA-CITRATED & EDTA American Scientific Products | JTL |
| Nov 1, 1982 | K822870 | STOOL-COLLECTION/PRESERVATION KIT American Scientific Products | KDT |
| Jun 25, 1982 | K821660 | BIO-CHECK GRAM STAIN CONTROL American Scientific Products | JTR |
| Apr 14, 1982 | K820683 | STAPHYLOCOCCUS LATEX AGGLUTINATION KIT American Scientific Products | LHT |
| Apr 8, 1982 | K820533 | B4182-1 American Scientific Products | GIE |
| Apr 8, 1982 | K820532 | DISPO FIBRIN PIPET TIPS B4182-2 American Scientific Products | GIE |
| Dec 31, 1981 | K813359 | MYCO-IMMUNE TM HISTOPLASMIN LATEX AGGL American Scientific Products | GMJ |
| Aug 31, 1981 | K812194 | IMMUNODIFFUSION BAND INTENSIFYING FLUID American Scientific Products | JZS |
| Aug 31, 1981 | K812193 | KOH MOUNTING FLUID American Scientific Products | LEB |
| Aug 31, 1981 | K812192 | LACTO-PHENOL ANILINE BLUE MOUNTING FLUID American Scientific Products | LED |
| Aug 31, 1981 | K812191 | VASPAR SEALENT American Scientific Products | KEO |
| Aug 31, 1981 | K812190 | COCCIDIOIDES IMMUNODIFFUSION SYSTEM American Scientific Products | GMI |
| Aug 31, 1981 | K812188 | CRYPTOCOCCAL ANTIGEN LATEX AGGLUTI American Scientific Products | GMD |
| Aug 31, 1981 | K812187 | SMITH'S SYSTEMIC FUNGAL MEDIUM American Scientific Products | JSI |
| Aug 25, 1981 | K812189 | COCCIDIOIDES LATEX AGGLUTINATION American Scientific Products | GMG |
| Aug 25, 1981 | K812186 | CANDIDA IMMUNODIFFUSION SYSTEM American Scientific Products | LHK |
| Aug 25, 1981 | K812185 | FUNGAL IMMUNODIFFUSION SYSTEM American Scientific Products | GMI |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||