ALKALINE PHOSPHATASE ISOENZY. SUB. SET
FDA 510(k) clearance K771620 · decided 1977-09-15
Clearance details
- K-number
- K771620
- Device name
- ALKALINE PHOSPHATASE ISOENZY. SUB. SET
- Applicant
- Pfizer, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1977-08-25
- Decision date
- 1977-09-15
- Days to decision
- 21 days
- Clearance type
- Traditional
- Product code
- CIN
- Device class
- 2
- Regulation number
- 862.1050
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Mchenry, IL, US
- Third-party review
- No
- Expedited review
- No
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| ACCESS OSTASE IMMUNOENZYMETRIC ASSAY (K994278) | Beckman Coulter, Inc. | 2000-03-28 |
| ALKPHASE-B ASSAY KIT (K981373) | Metra Biosystems, Inc. | 1998-05-27 |
| TANDEM-MP OSTASE IMMUNOENZYMETRIC ASSAY (K972666) | Hybritech, Inc. | 1997-09-11 |
| OPUS BONE ALP (K964764) | Behring Diagnostics, Inc. | 1997-01-24 |
| TANDEM-R OSTASE IMMUNORADIOMETRIC ASSAY (K961573) | Hybritech, Inc. | 1996-08-19 |
| ALKPHASE-B ASSAY KIT (K952768) | Metra Biosystems, Inc. | 1995-08-24 |
| RESOLVE SYSTEMS ALKALINE PHOSPHATASE TEST KIT (K934013) | Isolab, Inc. | 1994-04-26 |
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 |