AM-PEN SCREEN
FDA 510(k) clearance K782086 · decided 1979-02-01
Clearance details
- K-number
- K782086
- Device name
- AM-PEN SCREEN
- Applicant
- Pfizer, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1978-12-14
- Decision date
- 1979-02-01
- Days to decision
- 49 days
- Clearance type
- Traditional
- Product code
- JTO
- Device class
- 1
- Regulation number
- 866.2660
- Medical specialty
- Microbiology
- Advisory committee
- Microbiology
- Location
- Mchenry, IL, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Pfizer
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| IN-VITRO DIAGNOSTIC VAGINITIS TEST KIT (K050352) | Ameritek Research, LLC | 2005-09-01 |
| PYR SWAB (K970832) | Remel, Inc. | 1997-04-24 |
| GRAM SWAB (K970834) | Remel, Inc. | 1997-04-17 |
| INDOLE SWAB (K970833) | Remel, Inc. | 1997-04-02 |
| LYFO(TM) DIFFERENTIAL DISK-BACITRACIN (K970009) | Microbiologics, Inc. | 1997-02-06 |
| IDS RAPID CB PLUS SYSTEM (K962966) | Innovative Diagnostic Systems, Inc. | 1996-10-08 |
| COLISCREEN (K961191) | Hardy Diagnostics | 1996-06-17 |
| M. CAT BUTYRATE DISK (K960996) | Hardy Diagnostics | 1996-04-18 |
| GIBSON ID-M. CAT. (K955826) | Gibson Laboratories, Inc. | 1996-02-29 |
| DRYSLIDE CARTARRHALIS (K954783) | Difco Laboratories, Inc. | 1996-02-06 |
| LYFO(TM) DIFFERIENTAL DISK-PYR (K954812) | Microbiologics, Inc. | 1995-12-20 |
| GIBSON ID A.E. TEST (K953247) | Gibson Laboratories, Inc. | 1995-11-20 |
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| GELFOAM (absorbable gelatin gel, powder from abs. gel, sponge USP), GELFOAM (compressed absorbable gelatin sponge, USP), (N18286/S041) | Pfizer, Inc. | 2023-05-16 |
| (Gelfoam (absorbable gelatin) Sterile Sponge) (N18286/S040) | Pfizer, Inc. | 2022-06-24 |
| Gelfoam (absorbable gelatin) Sterile Sponge (N18286/S039) | Pfizer, Inc. | 2021-07-08 |
| Gelfoam (absorbable gelatin) Sterile Sponge (N18286/S038) | Pfizer, Inc. | 2021-05-07 |
| Gelfoam Sterile Sponge (N18286/S037) | Pfizer, Inc. | 2021-02-24 |
| Gelfoam (absorbable gelatin) Sterile Sponge (N18286/S036) | Pfizer, Inc. | 2020-12-10 |
| Gelfoam (absorbable gelatin) Sterile Sponge (N18286/S035) | Pfizer, Inc. | 2020-03-19 |
| Gelfoam (absorbable gelatin) Sterile Sponge (N18286/S034) | Pfizer, Inc. | 2020-02-27 |