Company ยท US
Gelman Sciences, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 1979 to 1995. Name variants (Inc, Corp, punctuation) are merged.
32510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| JJN | Apparatus, Electrophoresis, For Clinical Use | 5 |
| FMF | Syringe, Piston | 4 |
| FPB | Filter, Infusion Line | 3 |
| JRL | Unit, Filter, Membrane | 3 |
| DTM | Filter, Blood, Cardiopulmonary Bypass, Arterial Line | 2 |
| JBD | System, Analysis, Electrophoretic Hemoglobin | 2 |
| JJY | Multi-Analyte Controls, All Kinds (Assayed) | 2 |
| CZP | Iga, Antigen, Antiserum, Control | 1 |
| DIF | Drug Mixture Control Materials | 1 |
| DKB | Calibrators, Drug Mixture | 1 |
| DPA | Apparatus, General Use, Thin Layer Chromatography | 1 |
| FIB | Protector, Transducer, Dialysis | 1 |
| JHO | Electrophoretic Separation, Lipoproteins | 1 |
| JHT | Chromatographic Separation, Cpk Isoenzymes | 1 |
| JQT | Densitometer/Scanner (Integrating, Reflectance, Tlc, Radiochromat.) Clinica | 1 |
| KRJ | Filter, Prebypass, Cardiopulmonary Bypass | 1 |
| LBT | Electrophoresis, Cholesterol Via Esterase-Oxidase, Hdl | 1 |
| LIB | Device, General Purpose, Microbiology, Diagnostic | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Mar 17, 1995 | K946190 | DRUG DISPENSING SPIKE Gelman Sciences, Inc. | FMF |
| Sep 29, 1994 | K943127 | PHARMASSURE LARGE VOLUME TRANSFER FILTERS Gelman Sciences, Inc. | FPB |
| Sep 6, 1994 | K941589 | SYRINGE FILTER DEVICES Gelman Sciences, Inc. | FMF |
| Aug 10, 1994 | K941020 | DRUG RECONSTITUTION FILTER DEVICE Gelman Sciences, Inc. | FMF |
| Jul 26, 1994 | K942275 | VIAL VENT FILTER Gelman Sciences, Inc. | FPB |
| May 27, 1994 | K941032 | UNKNOWN Gelman Sciences, Inc. | FMF |
| Aug 12, 1991 | K910821 | TRANSDUCER PROTECTOR Gelman Sciences, Inc. | FIB |
| Jun 22, 1989 | K892387 | MODIFIED GELMAN ARTERIAL FILTER Gelman Sciences, Inc. | DTM |
| Apr 4, 1989 | K884176 | CHROMATOGRAPHY KIT Gelman Sciences, Inc. | DPA |
| Feb 17, 1989 | K884178 | DRUG CONTROL SET Gelman Sciences, Inc. | DIF |
| Feb 17, 1989 | K884177 | DRUG STANDARD SET Gelman Sciences, Inc. | DKB |
| Aug 8, 1986 | K862068 | GELMAN ARTERIAL FILTER (43, 33 AND 21 MICRON) Gelman Sciences, Inc. | DTM |
| Feb 27, 1985 | K850260 | GLEMAN ACD-2020 AUTOMATIC COMPUTING DENSITOMETER Gelman Sciences, Inc. | JQT |
| Feb 6, 1985 | K850202 | GELMAN TRIPHOR CONTROL Gelman Sciences, Inc. | JJY |
| Sep 11, 1984 | K842052 | GIARDIA GUARD Gelman Sciences, Inc. | LIB |
| Aug 10, 1984 | K842560 | OPTIPHOR-10 Gelman Sciences, Inc. | JJN |
| Aug 10, 1984 | K842485 | OPTICLEAR Gelman Sciences, Inc. | JJN |
| Jan 7, 1983 | K823550 | CK-ISOZYME U.V. REAGENT SET Gelman Sciences, Inc. | JHT |
| Aug 5, 1982 | K822121 | ACRO PACK Gelman Sciences, Inc. | JRL |
| May 12, 1982 | K821303 | HI-PHORE HIGH RESOLUTION ELECTROPHORES Gelman Sciences, Inc. | JJN |
| Apr 9, 1982 | K820518 | GELMAN GLYCO-PHORE BUFFER Gelman Sciences, Inc. | JBD |
| Dec 8, 1981 | K813159 | VACUSHIELD TM Gelman Sciences, Inc. | JRL |
| Oct 13, 1981 | K812539 | PRE-BYPASS FILTER Gelman Sciences, Inc. | KRJ |
| Sep 1, 1981 | K812253 | GELMAN IG-FIX KIT Gelman Sciences, Inc. | CZP |
| May 1, 1981 | K811100 | GELMAN ELECTROPHORESIS CONTROL Gelman Sciences, Inc. | JJY |
| Apr 8, 1981 | K810829 | ACRODISC Gelman Sciences, Inc. | JRL |
| Feb 5, 1981 | K810047 | AUTOPHOR 128 Gelman Sciences, Inc. | JBD |
| Jan 21, 1981 | K802765 | ACRODISC FILTER ASSEMBLY Gelman Sciences, Inc. | FPB |
| Jul 14, 1980 | K801378 | HIPP BUFFER(NON-BARBITAL), P/N Gelman Sciences, Inc. | JJN |
| Sep 17, 1979 | K791606 | GELMAN LIPOPROTEIN FRS SET. P/N 51213 Gelman Sciences, Inc. | JHO |
| Jul 30, 1979 | K791111 | AUTOMATED ELECTROPHORESES MACHINE Gelman Sciences, Inc. | JJN |
| Jun 15, 1979 | K790791 | ELECTROPHORESIS REAGENT SET, HDL Gelman Sciences, Inc. | LBT |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||